PAIN RELIEF MEDICATIONS BLOG

Alexza’s AZ-001 Phase IIb Trial Meets Primary Endpoint Of 2-Hour Pain Relief In Patients With Migraine Headache

March 28, 2007

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced positive top-line results from its 400 patient Phase IIb clinical trial of AZ-001 (Staccato(R) prochlorperazine) in patients with migraine headache. All three doses of AZ-001 met the primary endpoint of 2-hour pain-relief, compared to placebo. Alexza also announced today positive initial results from its Phase IIa clinical trial of AZ-004 (Staccato loxapine) in schizophrenic patients with acute agitation, where AZ-004 met the primary endpoint of the Phase IIa clinical trial.

“AZ-001 is a product candidate that we believe could fill an important unmet need in the treatment of patients with migraine headaches,” said Thomas B. King, President and CEO of Alexza. “AZ-001 combines drug delivery speed comparable to that of an intravenous injection, with the simplicity, convenience and ease of administration of a simple, one-breath inhalation. For the second time in Phase II trials, efficacy has been established for AZ-001, this time with dose-ranging information.”

“Prochlorperazine has long been administered intravenously with significant success in treating migraine headaches, usually in a clinic or in an emergency department,” said Anthony W. Fox, MD, PhD, President of the EBD Group and advisor to Alexza. “The ability to provide a therapy with an alternative mechanism of action, coupled with rapid pharmacokinetics in an outpatient environment, makes Staccato prochlorperazine an exciting drug candidate for many migraine patients.”

Clinical Trial Design

The AZ-001 Phase IIb clinical trial was an outpatient, multi-center, randomized, double blind, placebo-controlled study. The study was designed to evaluate the treatment of a single migraine attack in each of 400 migraine patients, with and without aura. In the trial, three doses of AZ-001 (Staccato prochlorperazine in 5, 7.5 and 10 mg doses) and placebo (a Staccato device containing no drug) were tested, with 100 patients assigned to each treatment group. The primary efficacy endpoint for the trial was headache pain relief at 2-hours post-dose, as defined by the International Headache Society (IHS) using a 4-point headache pain rating scale. Secondary efficacy endpoints for the trial included various additional measurements of pain relief, as well as effects on nausea, vomiting, phonophobia and photophobia. The clinical trial study period was 24 hours post dosing for each patient. All results were considered statistically significant at the p < 0.05 level and all analyses were made on an intent-to-treat basis. Side effects were recorded throughout the clinical trial study period and a safety evaluation was made at each patient's closeout visit.

Primary Efficacy Endpoint

AZ-001 met the primary efficacy endpoint of the clinical trial, which was pain relief at 2-hours post-dose using the IHS 4-point scale, for all three doses of the drug compared to placebo. Statistically significant improvements in pain response were observed in 66.0% of patients at the 10 mg dose (p=0.0013), 63.7% of patients at the 7.5 mg dose (p=0.0046) and 60.2% of patients at the 5 mg dose (p=0.0076), compared to 40.8% of patients receiving placebo.

Additional Efficacy Endpoints

Another measure of efficacy was the achievement of a pain-free response at 2 hours, where a patient has a pain score of 0 (or "no") headache pain at the 2-hours post-dose time point. In the trial, AZ-001, showed statistically significant differences from placebo in this measure with 35.0% of patients who received the 10 mg dose achieving pain-free status (p=0.0019) and 29.7% of patients who received the 7.5mg dose achieving pain-free status (p=0.0226). Patients receiving the 5 mg dose (21.4%) did not achieve a statistically significant pain-free response, compared to placebo. The rate of pain-free response at 2 hours in patients receiving placebo was 15.3%.

The Company believes duration of efficacy is an important consideration in developing migraine therapeutics. A commonly used measure of duration of efficacy is the sustained pain-free response, whereby a patient reports a pain-free score at the 2-hour post-dose time point and remains pain-free for the remainder of the study period (up to 24 hours). The 10 mg and 7.5 mg doses of AZ-001 showed statistically significant differences in sustained pain-free response, compared to placebo. Sustained pain-free outcomes through 24 hours were observed in 30.1% and 23.1% of total patients in the 10 mg and 7.5 mg dose groups, respectively. The placebo dose exhibited a sustained pain-free response in 10.2% of total patients.

AZ-001 exhibited rapid onset of pain relief. The 7.5 mg dose showed statistically significant pain response, compared to placebo, at 15 minutes (p=0.016). At 30 minutes, all three doses of AZ-001 showed statistically significant pain response, compared to placebo; 10 mg (p=0.0056), 7.5 mg (p=0.0003) and 5 mg (p=0.0056).

In addition to the various pain response analyses, the Company believes migraine-related symptom management is an important consideration in the overall efficacy of a migraine therapy. Important symptoms to be managed in migraine patients are nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound). Survival analyses for nausea, photophobia and phonophobia over the 2 hour time period post-dose showed a statistically significant difference, compared to placebo. The total patients with vomiting (n=20 in all four dose groups) in the trial were too few to make conclusions about drug effect.

Safety Evaluations

Side effects were recorded throughout the clinical trial study period and a safety evaluation was made at each patient's closeout visit. There were no serious adverse events reported during the trial. The most common drug- related side effects reported across all three active dose groups in the clinical trial were taste (25 - 33%), throat irritation (18 - 30%), cough (16 - 30%), somnolence (6 - 10%), breathlessness (2 - 9%), and dizziness (0 - 9%). These side effects appeared to be dose related, with a lower incidence and severity of the side effects generally seen at the lower doses of AZ-001.

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Pain Relief Made Easier - Consultation On Prescribing Of Controlled Drugs By Nurses And Pharmacists, UK

March 27, 2007

Main Category: Pain / Anesthetics News
Article Date: 27 Mar 2007 - 0:00 PDT
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The Government is today launching two consultations that aim to make it easier for patients to get the medicines they need by allowing:

- the prescribing of controlled drugs, including for pain relief, by nurse independent prescribers and pharmacist independent prescribers.
- the supply and/or administration of morphine and diamorphine under Patient Group Directions by nurses and pharmacists for the immediate necessary treatment of sick or injured persons

A 12-week Home Office consultation will look at whether the Misuse of Drugs Regulations should be updated to enable the prescribing of controlled drugs such as morphine for pain relief, by specially trained nurses and pharmacists.

The Medicines & Healthcare Products Regulatory Agency (MHRA) will simultaneously launch a consultation on proposals for changes to the legislation governing the supply and/or administration of pain relief through morphine and diamorphine by nurses and pharmacists working under Patient Group Directions.

In recent years, nurses and pharmacists have taken on increased responsibility for patient care by treating patients on a one-off basis, or by managing specialist clinics. These enhanced roles have improved access to and quality of patient care. However, limited access to appropriately qualified prescribers can result in a delay in a patient receiving medication and may inhibit a patient’s recovery.

Allowing Nurse and Pharmacist Independent Prescribers’ to prescribe Controlled Drugs will increase access to medicines for patients, improving care in areas such as palliative care, substance misuse, post-operative care and pain relief.

Health Minister Lord Hunt said

“These proposals will make it easier for patients to get the medicines they need without compromising safety. Enabling nurse and pharmacist prescribers to prescribe those controlled drugs they are competent to use, completes the changes we made last year and allows these highly trained professionals to use their full range of skills to help their patients.

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“As the NHS continues to reform and adapt to meet patient needs, patients are increasingly being treated by a broader range of health professionals and sometimes outside traditional healthcare settings. The proposed changes to medicines legislation will allow nurses and pharmacists to give pain relief quickly and safely to patients who need it. ”

Dr Peter Carter, General Secretary of the Royal College of Nursing (RCN), said

“The RCN has been calling for these changes which will improve the care and service for patients, so this is a welcome move. It shows that the Department of Health has listened to the views of the RCN and its members on this issue.”

“Nurses are highly trained and skilled. Last year 12,000 prescriptions for controlled drugs were written by nurses. Allowing appropriately trained and qualified prescribing nurses to prescribe more controlled drugs within their competency and speciality, and allowing nurses to supply and administer more controlled drugs under patient group direction will ensure that nurses can take a more active role in ensuring that patients’ symptoms are well managed. This is good news for nurses and good news for patients.”

Both consultations, if accepted, would make better use of the skills of healthcare professionals and contribute to the introduction of more flexible team working across the NHS.

The Advisory Council on the Misuse of Drugs (ACMD) will consider the responses to both consultations, before making recommendations to Home Office Ministers. The Commission on Human Medicines (CHM) will also consider the responses to the consultation on Patient Group Directions before making recommendations to Department of Health Ministers. Any changes arising from the ACMD and CHM’s recommendations would be introduced by Statutory Instrument, no earlier than late summer 2007.

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Back pain relief without surgery

March 15, 2007

BOCA RATON, Fla. — Back pain is a huge problem in the United States, and there aren’t a lot of successful treatments. One promising technique, called spinal mobilization, has been around since the 1920s, but it’s a difficult procedure for therapists to perform. They’re often left with arthritis and crippled hands. Now, a new device used in Britain is here in the United States to help.

Running his own tire company keeps Lindsey Clark busy, but severe back pain after a recent car accident kept him from doing his job. “I couldn’t walk, couldn’t come to work, couldn’t find any place comfortable to sit,” he said.

Clark tried everything — pain killers, surgery, physical therapy, even acupuncture, but nothing relieved the pain. Then he found help from an unlikely source … a device long used in Europe to relieve back pain that was just recently introduced to the United States. It’s called powered spinal mobilization.

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Back pain relief without surgery

Back pain is a huge problem in the United States, and there aren’t a lot of successful treatment

“We didn’t invent mobilization. We’re just bringing a device to the practitioners to help them do a better job at it,” Jeffrey Perelman, M.D., a back pain specialist at Advanced Spinal Technologies in Boca Raton, Fla., explained.

Dr. Perelman says when back pain happens, the spine stiffens to protect itself. Therapists used to mobilize the spine by applying pressure with their hands, but now a device does all the work by gently rocking opposing vertebrae.

“We really give patients their life back,” he said. “That’s the most thrilling thing as a physician that I could possibly have the opportunity to be involved with.” In one 30 minute session, the device can do what therapists used to do in 20 visits.

Powered spinal mobilization can be used on patients with all types of back pain except those who are susceptible to fractures. Patients typically start with treatment sessions two to three times a week for four weeks. Then, they’ll need maintenance sessions every couple of weeks. Most insurance companies will cover the cost of spinal mobilization. The Advanced Spine Mobilization Instrument is FDA approved in the United States and is being used at select clinics around the country.

At first, Clark was skeptical, but after the first five treatments, he was a believer. “I walked out of there at 4:30 one afternoon, and I was just totally pain-free,” he added. “My attitude is fantastic. My whole quality of life has changed tremendously.

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The fresh agonies of our returning soldiers

March 13, 2007

Jamie Cooper begged for his colostomy bag to be emptied. In all, he asked three nurses. One said she had no idea how to help. Another promised to pass on his request. His parents watched the plight of their wounded soldier. He may as well have begged for his dignity.

Cooper had served, and nearly died for, his country. Shrapnel had sliced through his stomach after a mortar attack in Basra last November. He remains the youngest British serviceman wounded in Iraq. Now the 18-year-old was struggling to have his faeces removed at the Birmingham hospital that treats the most seriously wounded from Iraq and Afghanistan. Finally his parents could take no more: they emptied the bag themselves.

‘We went to the store room, helped ourselves to the necessary equipment and proceeded to clean out the colostomy bag - a task too onerous for staff,’ Phillip and Caroline Cooper wrote in a letter last month to senior military leaders and NHS staff, which has been obtained by The Observer.

The Royal Green Jacket rifleman remains at Selly Oak Hospital, the sprawling NHS complex in south Birmingham where the most serious of Britain’s returning wounded are treated. The lucky ones arrive at ward S4, where nurses attend to two six-bed bays in a ‘military-managed’ unit. Some are treated alongside civilians, removed from the camaraderie of wounded colleagues. Six months after the heated row over the suitability of placing wounded troops in mixed-civilian wards, Selly Oak is facing far more serious allegations. Letters obtained by The Observer have been called into question the treatment afforded to Britain’s injured troops. The claims have provoked fresh consternation over how Britain treats its war-wounded and uncomfortable questions for a government embroiled in two bloody conflicts.

Weeks after the scandal surrounding shoddy conditions at America’s flagship military hospital, the Walter Reed Army Medical Center in Washington, the British government faces its own crisis over a hospital where hundreds of wounded service personnel have arrived since the Iraq invasion four years ago.

An extraordinary sheaf of letters sent to the Ministry of Defence and the NHS and passed on by military sources to The Observer chronicles a series of alleged failings in basic care and services given to UK soldiers. Among them are claims that troops have been denied pain relief after wards ran out of supplies. On one occasion, wounded soldiers were allegedly forced to wait more than 12 hours for pain-relieving medication.

One letter of complaint from anxious parents, dated 24 February, suggests that wounded soldiers may be suffering more than is necessary in Selly Oak.

The operation on their son finished at 8pm and left their son in ‘acute agony’. His ordeal had only just begun.

‘The pain team is only on duty 9am to 5pm and it was only at 10.30am the next day that his pain was addressed. Presumably the call-out is too expensive,’ wrote one couple from Oxfordshire.

In separate correspondence, Alex Wheldon of 45 Commando Royal Marines claims that his pain relief in Selly Oak ‘arrived two-and-a-half hours late’ and even then was incomplete. Another 45 minutes passed before the corporal received his designated dosage.

Other letters suggest soldiers may have received the wrong tablets. On another, 12-hour pain-relief tablets were not issued because supplies were exhausted. Wheldon, who spent weeks in ward S4 earlier this year after being shot fighting the Taliban, describes a fellow soldier from Afghanistan in such agony on the ward that it ‘brought tears to his eyes’. Wheldon alleges that hospital staff implied the soldier’s suffering was imaginary. ‘Certain staff seemed to think it was a psychological problem and made him go and speak to a ’shrink. But it was physical,’ he adds.

Cooper, too, is alleged to have suffered pain and humiliation during his treatment. In one instance, four days before last Christmas, the teenager was denied pain-relief because of a lack of qualified trained staff, according to the letter from his parents.

Though help was eventually forthcoming, they say, the problems remained. ‘When they [the pills] were administered, Jamie was given the wrong tablets,’ his parents wrote. The family, from Bristol, says that, during their son’s stay in Selly Oak, his colostomy bag was twice allowed to overflow. During the night of 29 November, he was forced to lie in his faeces. His wounds, according to his parents’ testimony, actually worsened following his life-saving operation, the pressure sores on his heel deteriorating so much that he required skin-grafts.

Twenty days from now, the last of Britain’s military hospitals will close. Little more than a decade ago, Britain had eight such institutions. During the First World War, there were 20, with at least 9,200 beds reserved for soldiers.

‘We will be the only country in the civilised world without a dedicated military hospital’, said Hampshire councillor Peter Edgar, who is campaigning against the imminent closure of the Royal Naval Hospital Haslar in Gosport.

The withdrawal of MoD funding comes as casualties steadily mount in Afghanistan and Iraq. Four British soldiers have been killed in Helmand in the past eight days. So far, more than 5,500 wounded have been airlifted back to Britain for treatment.

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About 800 are understood to have passed through Selly Oak. Wheldon had seen enough after three weeks in ward S4. His complaints, written during his stay at the hospital, are not merely his own. His detailed litany of concerns are echoed by ‘every’ other patient soldier he met at Selly Oak, headquarters of the Royal Centre for Defence Medicine.

All were exhausted during their time at the hospital. Wheldon managed a maximum of four hours’ sleep because of the incessant clattering of bins and trolleys by auxiliary nurses and civilian staff throughout the night. The repercussions, wrote the corporal, were more damaging than simply a lack of rest.

‘The military men from Afghanistan and Iraq jump with shock,’ Wheldon said. ‘A sudden crash or bang goes through you, especially for us who have been mortared or been under heavy fire. It is a subconscious reaction which isn’t very pleasant.’

Wheldon describes how an army sergeant once almost leapt out of his bed with fright. It is indicative, he writes, of a perceived lack of respect and understanding by the NHS towards armed forces families in Selly Oak. ‘An army patient in my bay, a casualty from Iraq, had not seen his wife or baby son for five months. They were due to arrive, after a four-hour journey, earlier than the visiting time allows. He was told they would have to wait until the designated time.’

Wheldon’s mother also complained of shabby treatment. Her letter, dated 16 February, claims that the visitor room for military families ‘appears to be more of a store room for large equipment’ and that it was so cramped ‘there is not really enough room for more than one family’. And it was grubby, she notes: ‘Could it not be cleaner? The overall impression I have got is one of untidiness and grubbiness on the ward’.

Cooper contracted MRSA twice while he was in Selly Oak. His parents were left in little doubt that ‘there is a need to reinforce simple measures in hygiene’. Yet, still no one knows how many British troops have caught the infection after returning to Britain. The MoD, in a parliamentary answer last week, explains that no central figures are available.

Food given to wounded troops is also described as inadequate in the letters. On arriving at Selly Oak, Wheldon was told that a decent diet would promote healing. He writes of ’stale sandwiches’ and being forced to buy his own meals at the hospital canteen. Some issues seem easily avoidable. Wheldon describes how one soldier was told by a Selly Oak consultant before an operation that ‘his military career could be over’. He adds: ‘A simple sentence like that, can, and did, have a profound effect on the man’s mental state.’

Perhaps Wheldon could count himself fortunate in one respect. At least he had comrades for company. Cooper’s misery was compounded by his isolation in a room with no television or radio for distraction. ‘We would, if possible, have taken our son into private care. However, if we had done so, then he would have been classed as AWOL,’ his parents wrote.

Sometimes, though, company can prove troublesome. The Oxfordshire parents describe how their son was rudely disturbed one night in Selly Oak. ‘It is outrageous that an injured soldier should be disturbed at night by a disorientated geriatric trying to get into his bed in error.’

Isolation can sap a soldier’s spirit. In a letter dated 5 March to Prince Charles and senior commanders, a parent from Doncaster claims that her son is suffering after being sent to an NHS hospital in Putney, rather than the military’s rehabilitation centre.

The woman recently gave up her career to look after her seriously wounded 22-year-old son, who is in 7 Parachute Regiment, Royal Horse Artillery. ‘Surely there is a place at Headley Court [a specialist military treatment centre] for a boy such as Ben, who has sacrificed so much for his country?’

Wheldon received a reply from the head of the Royal Centre for Defence Medicine on 22 February. It admits that ‘many of the matters you raise are known’ and said they would be investigated.

Days earlier, the Coopers received a response. A formal investigation is under way into their complaints. ‘Your son will never be just another statistic to RCDM,’ they were assured.

Some remain unconvinced. As Wheldon concludes: ‘We’ve just spent four months fighting in the chaos of another world, where every day you risk losing your life at any moment. There’s no way we would ever ask for sympathy; that is not our style. All we ask for is understanding’

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Study finds ibuprofen best for pain relief in children

March 8, 2007

Canadian researchers have said that a comparison study of three common painkillers has found that ibuprofen was the most effective at treating pain in children.

They discovered that the pain killer was most effective for children with broken bones, bruises and sprains. Ibuprofen beat generic acetaminophen and codeine in a study of 300 children treated at a Canadian hospital.

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The children enrolled were six to 17 years old with pain from a musculoskeletal injury to extremities, neck, and back that occurred in the preceding 48 hours before presentation in the emergency department.

The primary outcome was change in pain from baseline to 60 minutes after treatment with study medication as measured by using a visual analog scale.

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The children asked to show how much pain they were feeling by placing a mark on a horizontal pain intensity scale from 0 to 100. This is the visual analogue scale, and in this case it measured 100 mm wide.

Patients in the ibuprofen group had a significantly greater improvement in pain score with a mean decrease of 24 mm than those in the codeine with a mean decrease of 11 mm, and acetaminophen which had a mean decrease of 12 mm at 60 minutes.

In addition, at 60 minutes more patients in the ibuprofen group achieved adequate analgesia than the other two groups. There was no significant difference between patients in the codeine and acetaminophen groups in the change in pain score at any time period or in the number of patients achieving adequate analgesia

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Study Shows Nonsurgical Treatment Reduces Neck Pain Without Significant Risk of Paralysis

March 6, 2007

In the largest series of patients to date, recent research shows that the translaminar approach to cervical spinal steroid injections can reduce neck pain in eighty-three percent of those treated. In addition to being an effective treatment, the translaminar approach was found to be safer than an alternative method or surgery, as no major complications were observed. In the alternative approach, steroids are injected in close proximity to nerve bundles and small blood vessels in the spine, which can result in nerve damage or paralysis. The translaminar technique in the study avoids this risk by injecting the steroids into the epidural space in the neck, allowing the drug to spread up and down the spine to reduce the inflammation and subsequently reduce pain. This safer translaminar approach is an outpatient treatment, requiring only a small amount of local anesthesia. Although the injection does not treat the underlying cause of the pain, such as arthritis or herniated disc, it does treat the immediate pain flare-up, allowing patients to get back to their normal routines. The research was presented today at the Society of Interventional Radiology’s 32nd Annual Scientific Meeting in Seattle.

“Although the other approach offers pain relief, there is increased risk of major complications such as paralysis. This study shows the translaminar approach is just as effective, but without the risk,” explained lead researcher William M. Strub, M.D., of the University of Cincinnati, who completed the study with interventional radiologists based at The Christ Hospital. “This procedure can help provide pain relief in patients with neck pain from bulging discs, arthritis, and even in patients who continue to have pain after cervical spine surgery. It’s well tolerated, outpatient, nonsurgical, safe and effective, and as such, we expect this approach to become the gold standard for reducing patients’ neck pain.”

The neck pain treated by these steroid injections was due to aging of the spine. This includes degenerative changes such as osteoarthritis of the spine, bone spurs, disc degeneration and narrowing of the spinal canal. Additional alternative treatments for neck pain are physical therapy, traction, narcotic and non-narcotic pain medication and, in some cases, surgery.

During the procedure, an interventional radiologist utilizes real-time, continuous X-ray imaging to guide a small needle into the base of the neck between the C7 and T1 vertebrae, the largest epidural space in the neck, and injects a small amount of medication. The medication then spreads up and down the spine to reduce the inflammation in the spine, reducing pain. The patient is kept awake to enable communication with the physician, but the skin is numbed. After a brief observation period, the patient is released the same day. Patients receive between one and three injection treatments with approximately three to four weeks between the procedures. Typically, patients who will be the most responsive to the translaminar injection will notice the greatest amount of pain reduction after the first treatment. The translaminar steroid injection is ideal for patients who are not receiving adequate relief from over-the-counter pain medications, but who are not ready for spine surgery.

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About the Study

The study’s patient population consisted of 161 patients, 69 males and 92 females, with an average age of 53. Patients experienced pain, on average, for four months before undergoing their first injection. 119 patients had multiple injections — 87 had two and 32 had three. The average length between procedures was four weeks. There were no major complications. Of those treated, only five percent had minor complications, primarily side effects from steroids such as weight gain and hot flashes. The treatment resulted in pain relief in eighty-three percent of patients. Additionally, the research showed that patients with radiating pain to the hands and fingers, as opposed to more localized pain, had higher odds of improved pain relief. Abstract 206 can be found at http://www.sirmeeting.org/.

“This research was performed by five interventional radiologists at three institutions on 161 patients, all with outstanding results and no major complications, showing that these results are reproducible,” added Strub. “It is important for patients to find a physician who is well-trained in these procedures and image-guided treatments, as well as one who has an intricate understanding of spinal anatomy before having steroid injections performed.”

About the Neck

The cervical portion of the spine (neck) is made up of seven bones (C1-C7 vertebrae). Intervertebral discs separate each vertebra and act as shock absorbers for the spine. Boney knobs, called facets, extend from each vertebra and stack on top of each other creating a chain-like effect, known as a facet joint, which allows the neck to bend and turn. Additionally, thick rubber band-like ligaments connect to each vertebra to provide stability. The ligaments also provide support for the head and allow for range of motion. All the nerves to the rest of the body (arms, chest, abdomen and legs) pass down through the spinal canal in the neck before making their way to the rest of the body-making a cervical spinal cord injury a serious condition that can affect a patient’s quality of life. The neck can be vulnerable to injury resulting in pain and restricted motion because it is less protected than the other parts of the spine that are partially protected by the chest and abdomen.

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