PAIN RELIEF MEDICATIONS BLOG

Has Science Unearthed The Holy Grail Of Pain Relief?

July 26, 2007

The findings — published in the journal Nature — could rapidly advance research into the next generation of painkillers for relief of chronic conditions such as migraine and backache.

Chronic pain, unlike the acute pain associated with trauma, has no apparent physiological benefit, often being referred to as the ‘disease of pain’.

Complete and lasting relief of chronic pain is rare and often the clinical goal is pain management through one or more medications.

But now researchers at The University of Manchester have examined microscopic amoeboid organisms commonly called slime moulds in a bid to gain greater insight into these pain molecules, known as ‘P2X receptors’.

“In humans, P2X receptors look identical to one another and so scientists have had difficulty understanding how they function,” said Dr Chris Thompson, who carried out the research with Professor Alan North and Dr Sam Fountain in the Faculty of Life Sciences.

“By looking at slime mould we were effectively able to turn the evolutionary clock back a billion years to see how a more primitive P2X molecule functions.”

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The team discovered that there was only a 10% similarity between human P2X and the slime mould equivalent. They were therefore able to deduce from evolutionary theory that it was these similar parts of the molecule that probably regulate pain in humans.

“It’s a big step forward in understanding how the molecule works and should make it possible to develop drugs that block the receptors’ actions,” said Dr Thompson.

“Inhibiting P2X as a potential pain-relief therapy would be the Holy Grail of rational drug design and could revolutionise the way we manage chronic pain conditions like back pain and migraine.”

The research, published in Nature Thursday, July 12, was funded by the Wellcome Trust, the Medical Research Council and the Lister Institute for Preventive Medicine.

About slime mould

In nature, the slime mould Dictyostelium exists as single-cell amoebae feeding off bacteria in the soil. When their food supply runs out they aggregate to form a ‘fruiting body’ of some 100,000 cells. Some cells become spores, while others form a stalk beneath the soil surface. These stalk cells die; they sacrifice themselves so the spores can be dispersed to new feeding grounds.

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Health Canada expands use of new COX-2 inhibitor

July 25, 2007

Novartis Pharmaceuticals Canada Inc. announced today the expanded Health Canada approval of Prexige(*) (lumiracoxib) for the acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) in adults. Initially approved for OA of the knee in November 2006, Prexige is a unique selective COX-2 inhibitor that provides osteoarthritis patients with an effective and safe option for controlling pain, improving their mobility and quality of life.(1) “This new treatment is welcome news for many patients who have had no choice but to endure the debilitating effects of osteoarthritis with little relief from their pain,” says Dr. Jameel Razack, a family physician in Toronto. “With Prexige, we now have a much needed option to offer our osteoarthritis patients that can effectively and safely reduce their joint pain and improve their mobility.” After living with osteoarthritis for many years, George Soteroff, a Toronto business executive, had run out of options to control the pain in his knees. Then, a few months ago, Mr. Soteroff’s doctor prescribed a new treatment that allowed him to take back control of his disease, and his life. “I was at the point where my knee pain was unbearable and the only treatment left for me wasn’t controlling it. I had run out of options and it was very frustrating for me, and for my doctor,” recalls Mr. Soteroff. “My entire life was affected - mornings were slowed down by pain and stiffness, getting around during the day wasn’t much easier, and playing golf was very difficult.” Uncontrolled pain from OA can have a serious impact on a patient’s physical and emotional well-being, which can significantly reduce the overall quality of life for the three million Canadians battling this disease.(2) These patients rely on a variety of treatment options to control their pain, because not all respond to medications in the same way. But, in recent years, effective and safe options to treat OA pain have become increasingly limited, leaving more than one in five patients without sufficient pain relief from their current non-steroidal anti-inflammatory drug (NSAID) therapy.(3) Most common form of arthritis OA is the most common form of arthritis, impacting the lives of more than three million Canadians (1 in 10). The disease affects the joints in the body and usually involves the hands and weight-bearing joints such as hips, knees, feet and spine. OA can occur at any age but most people develop it after the age of 45. Symptoms usually come on slowly and include pain and stiffness or swelling around the joints.(2) “Uncontrolled osteoarthritis symptoms can lead to reduced mobility, muscle deterioration and a further increase in joint pain,” said John Fleming, President and CEO, The Arthritis Society. “It is always a good day when new treatment options become available for people with osteoarthritis. We urge governments, as we always do to recognize the needs of people living with the pain of arthritis to have timely access to all medications approved for use in Canada.” In fact, many patients like George Soteroff depend on effective and safe treatment options like Prexige to lead productive and active lifestyles. “Once I started taking Prexige, I noticed immediate and significant improvements, from first thing in the morning and lasting all day,” says Mr. Soteroff. “My knees are not sore and the joints are much looser. I walk without a limp now, rather than a stagger, and I recently played nine holes of golf, pulling a heavy golf cart up and down hills - a first in a couple of years!” he adds. About Prexige Prexige works by blocking cyclooxygenase-2 (COX-2), an enzyme that promotes joint inflammation, while sparing another similar enzyme called COX-1 which helps protect the mucous lining in the stomach, unlike traditional NSAIDs.

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Prexige is considered unique because it is rapidly cleared from the body, it reaches a higher concentration in the joint synovial fluid, and it is preferentially retained in inflamed tissue, allowing for once per day dosing.(4) Prexige is the first COX-2 selective inhibitor to be approved in Canada since the withdrawal of two medications in the same class, in 2004-2005. COX-2s were first marketed in Canada in 1999 as anti-inflammatory medications that caused less gastrointestinal side-effects (e.g. ulcers) than traditional NSAIDs, such as ibuprofen. Following the COX-2 withdrawals, several expert bodies in arthritis held a consensus conference, in 2005, and identified a gap in pain relief for the three million Canadians living with OA. This group, and the arthritis community, concluded that patients need a variety of medications, including COX-2 inhibitors, which are effective and safe. Initially approved for OA of the knee in November, 2006, Prexige has the largest body of evidence supporting the launch of an NSAID, traditional and COX-2, with a clinical trial database of over 34,000 patients. In the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), the largest safety outcomes study published in OA (18,325 patients), Prexige, at four times the recommended OA dose, was compared to the traditional NSAIDs ibuprofen and naproxen.(5,6) TARGET found that Prexige provided a 79 per cent reduction in the incidence of upper GI ulcer complications, among non-aspirin users, in comparison to those treated with traditional NSAIDs naproxen and ibuprofen.(5,6,7) The treatment also showed no significant difference in risk of cardiovascular events, such as heart attack or stroke compared to the other NSAIDs.(6) Recent data presented at the 2007 Annual European Congress of Rheumatology showed that Prexige has significantly less impact on blood pressure than ibuprofen, a commonly-used NSAID.(8) These new results are important because approximately 40 per cent of patients with osteoarthritis also have high blood pressure (or hypertension).(9,10) Novartis is committed to ensuring that Prexige is prescribed appropriately and has launched a comprehensive, long-term study to monitor 20,000 Canadian patients on selected NSAIDs/COX-2 inhibitors, including Prexige. This first-of-its kind, real-life study will further build on the strong body of safety evidence available on Prexige. This commitment will be further supported through strong health education programs for physicians and pharmacists across the country. Forward-looking statement The foregoing release contains forward-looking statements that can be identified by terminology such as “strong,” “sustained pain relief,” “significant” or similar expressions, or by express or implied discussions regarding potential additional marketing approvals or future sales of Prexige. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Prexige to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Prexige will receive any additional marketing approvals in any other countries, or that it will reach any particular sales levels. In particular, management’s expectations regarding commercialization of Prexige could be affected by, among other things, additional analysis of Prexige clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government, industry, and general public pricing pressures; and other risks and factors referred to in the Company’s current Form 20-F on file with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Canada Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. Novartis Pharmaceuticals Canada conducts hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, diabetes, cancer, organ transplantation, musculoskeletal diseases and ophthalmic diseases. In 2006, the Company invested over $69 million in research and development. Novartis Pharmaceuticals Canada Inc. employs approximately 850 people in Canada and its headquarters are located in Dorval, Quebec. In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in Canada consists of Novartis Animal Health Canada Inc.

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Implant Gives New Alternative For Neck Pain Relief

July 21, 2007

It used to be if you had a bad disc in your neck, the only solution was to remove it and fuse your vertebrae together.

The recovery was long and it left patients with less ability to move their necks, but there’s a new alternative and a local hospital helped develop it.

The prestige cervical disc is a new implant approved by the Food and Drug Administration.

It’s the first artificial disc for the neck. The implant is two pieces of stainless steel with a ball and groove construction. This allows for some movement.

The spine in the neck consists of seven bones. In between the bones is a spongy, cushiony disc which allows for rotation and bending.

Traditionally, surgical treatment involves removing a diseased disc and fusing two or more of the bones.

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With the new implant, the doctors take out the discs that aren’t working right. They attach the artificial disc into the neighboring neck bones.

“For the first time we have a motion-preserving device that lets you keep motion in your spine,” Dr. Donald Whiting, from Allegheny General Hospital, said.

FDA approval is based on research in more than 500 people which showed this procedure is just as safe and effective as the traditional approach.

“What we don’t know yet is will it reduce the wear and tear on the levels above and below,” Whiting said. “Ten years down the road, 20 years down the road, we don’t know, we may have to go back in and correct it.”

Right now, insurance may not cover it and further study over the next seven years will look at longer term safety and effectiveness.

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DURECT Reports Positive Results from POSIDUR(TM) Phase IIb Hernia Trial, Triggering $8 million Milestone Payment from Nycomed

July 17, 2007

DURECT Corporation announced today positive results from a 122 patient Phase IIb clinical trial of POSIDUR(TM) for treatment of post-operative pain in patients undergoing inguinal hernia repair. This Phase IIb trial was designed to be the study upon which DURECT and its collaborator Nycomed would base their decision for advancing POSIDUR into Phase III clinical trials. In the trial, POSIDUR demonstrated statistically significant reductions in pain and total consumption of supplemental opioid analgesic medications versus placebo. These successful results trigger an $8 million milestone payment to be made by Nycomed to DURECT under the parties’ collaborative agreement. In preparation for the Phase III program, DURECT has scheduled an end-of-Phase II meeting with the U.S. Food and Drug Administration (FDA).

(LOGO: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO)

“We believe that the results of our Phase IIb trial support the validity of our POSIDUR product concept of simultaneously relieving pain while reducing opioid consumption,” stated James Brown, President and CEO of DURECT Corporation. “Our partnership with Nycomed provides us with financial and development support along with a strong marketing presence to commercialize POSIDUR in Europe and other countries. We intend to market POSIDUR ourselves in the U.S., if approved, thus providing us with a pathway to establishing our own specialty pharmaceutical business.”

Phase IIb Inguinal Hernia Trial

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Design

The POSIDUR Phase IIb clinical trial was designed to evaluate the tolerability, activity, dose response and pharmacokinetics of POSIDUR in patients undergoing open inguinal hernia repair. The study was conducted in Australia and New Zealand as a multi-center, randomized, double blind, placebo-controlled study in 122 patients. Study patients were randomized into three treatment groups: patients that were treated with POSIDUR 2.5 mL (n=43), POSIDUR 5 mL (n=47) and placebo (n=32). The co-primary efficacy endpoints for the study were Mean Pain Intensity on Movement area under the curve (AUC), a measure of pain over a period of time, 1-72 hours post-surgery, and the proportion of patients requiring supplemental opioid analgesic medication during the study. Secondary efficacy endpoints included Mean Pain Intensity on Movement AUC over the period 1-48 hours post-surgery, mean total consumption of supplemental opioid analgesic medication, and time to first use of supplemental opioid analgesic medication. The threshold for statistical significance was considered to be at the p<0.05 level.

Results

Pain Control

In relation to the co-primary endpoint of pain reduction as measured by Mean Pain Intensity on Movement AUC 1-72 hours post-surgery, the patient group treated with POSIDUR 5 mL reported thirty-one percent (31%) less pain versus placebo (p=0.0033). A thirty-five percent (35%) reduction of pain as measured by Mean Pain Intensity on Movement AUC for the period 1-48 hours post-surgery, a secondary endpoint measure, was reported between the POSIDUR 5 mL treatment group versus placebo (p=0.0007).

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Has science unearthed the Holy Grail of pain relief?

July 11, 2007

Scientists studying one of nature’s simplest organisms have helped to unravel the structure of a key molecule that controls pain in humans.

The findings - published in the top scientific journal Nature - could rapidly advance research into the next generation of painkillers for relief of chronic conditions such as migraine and backache.

Chronic pain, unlike the acute pain associated with trauma, has no apparent physiological benefit, often being referred to as the ‘disease of pain’.

Complete and lasting relief of chronic pain is rare and often the clinical goal is pain management through one or more medications.

But now researchers at The University of Manchester have examined microscopic amoeboid organisms commonly called slime moulds in a bid to gain greater insight into these pain molecules, known as ‘P2X receptors’.

“In humans, P2X receptors look identical to one another and so scientists have had difficulty understanding how they function,” said Dr Chris Thompson, who carried out the research with Professor Alan North and Dr Sam Fountain in the Faculty of Life Sciences.

“By looking at slime mould we were effectively able to turn the evolutionary clock back a billion years to see how a more primitive P2X molecule functions.”

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The team discovered that there was only a 10% similarity between human P2X and the slime mould equivalent. They were therefore able to deduce from evolutionary theory that it was these similar parts of the molecule that probably regulate pain in humans.

“It’s a big step forward in understanding how the molecule works and should make it possible to develop drugs that block the receptors’ actions,” said Dr Thompson.

“Inhibiting P2X as a potential pain-relief therapy would be the Holy Grail of rational drug design and could revolutionise the way we manage chronic pain conditions like back pain and migraine.”

The research, published in Nature today (Thursday, July 12), was funded by the Wellcome Trust, the Medical Research Council and the Lister Institute for Preventive Medicine.

Ends

Notes for editors:

In nature, the slime mould Dictyostelium exists as single-cell amoebae feeding off bacteria in the soil. When their food supply runs out they aggregate to form a ‘fruiting body’ of some 100,000 cells. Some cells become spores, while others form a stalk beneath the soil surface. These stalk cells die; they sacrifice themselves so the spores can be dispersed to new feeding grounds.

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Anesiva Announces Phase 2 Data Showing Substantial, Long-Term Pain Reductions with Adlea(TM) (formerly 4975) in Osteoarthritis of the Knee

July 2, 2007

SOUTH SAN FRANCISCO, Calif., July 2 /PRNewswire-FirstCall/ — Anesiva, Inc. today announced preliminary longer-term, follow-up results from a Phase 2 study showing that a 1mg treatment with Adlea(TM) (formerly 4975) in patients with moderate-to-severe osteoarthritis of the knee produced substantial reductions in pain that persisted for up to 12 weeks.

“The positive preliminary results from this knee pain study further strengthen our belief that Adlea will prove to be a safe and effective drug in multiple osteoarthritis indications,” said John P. McLaughlin, chief executive officer of Anesiva. “We are on-track to advance Adlea into late-stage trials in various indications this summer, including a Phase 2/3 trial for osteoarthritis of the knee.”

Fifty-five patients with osteoarthritis of the knee were randomized to receive either: (I) a single injection of 1 mg of Adlea (n=36) or (II) three stepped ascending weekly doses totaling 1 mg of Adlea (n=19). At baseline prior to treatment, approximately three quarters of the patients had moderate pain while the other quarter had severe or extreme pain. As was previously reported, patients treated with Adlea demonstrated a 61 percent reduction in mean pain intensity from baseline to week one, and the analgesic effect was sustained at all subsequent weeks to the last scheduled in-clinic assessment at week eight, at which time a 64 percent reduction in pain from baseline was reported. At week 12, pain reductions were sustained. A cohort of 50 patients showed a 65 percent reduction from baseline pain scores. Forty two percent of the patients reported “no pain,” 44 percent had “mild pain,” and only 14 percent reported “moderate” or “severe” pain. The lengthy duration of clinical benefit is consistent with the known mechanism of action that suggests treatment with Adlea administered as a single injection or stepped doses leads to pain relief durable for 12 weeks in patients suffering from moderate to severe pain due to knee osteoarthritis.

The following table summarizes the reduction in pain scores provided by the use of Adlea compared to baseline pain scores. A scale of 0-4 (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain and 4 = extreme pain) was used in the study:

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How Adlea May Address Need for Long-Duration, Well-Tolerated Pain Relief

Adlea is long-acting, with the potential to provide pain relief for weeks or months after just a single localized treatment. It is a non-opioid TRPV1 agonist with a unique mechanism of action that provides a long-lasting, localized effect on C-fibers and blocks the transmission of aching, throbbing pain caused by major surgical procedures and end-stage osteoarthritis. Because it selectively acts on pain-sensing nerve endings, Adlea does not affect other nerve fibers necessary for sensory or motor sensations, such as those needed to sense temperature or pressure. In clinical studies to date, Adlea has not had the side effects often associated with other conventional pain medications and has been shown to be well tolerated.

Pharmacokinetic studies of Adlea showed that when it is locally administered to the site of pain, there appears to be limited systemic exposure. Its short duration of systemic exposure (hours) relative to the long duration of analgesia (12 weeks) resulting from a single treatment course of Adlea is particularly important in this typically elderly and vulnerable patient population and may potentially offer a safer treatment option in the management of chronic osteoarthritis pain. Importantly, the prolonged analgesic effect resulting from a single or stepped dose, localized administration of Adlea does not seem to be associated with the systemic side effects commonly associated with NSAIDs (gastrointestinal and renal toxicities, and impaired clotting), COX-2 inhibitors (cardiovascular risks and renal toxicity), or opioids (respiratory depression, nausea/vomiting, sedation, disorientation, physical dependence, and the risk of addiction).

About Osteoarthritis of the Knee

Osteoarthritis of the knee is a common, progressive disease in which the joint cartilage breaks down. This breakdown causes the bones to rub against each other resulting in stiffness, pain, and loss of movement in the joint. In advanced stages, the pain becomes intractable and disabling, limiting patients’ mobility and activities. At least five million patients in the U.S. are suffering from moderate to severe osteoarthritis of the knee and are candidates for knee replacement or aggressive non-surgical interventions to address the debilitating effects of end-stage osteoarthritis of the knee.

About Anesiva and its Diverse Pipeline of Pain Products

Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has two drug candidates in development for multiple pain-related indications. A New Drug Application (NDA) has been filed for the most advanced product, Zingo(TM). The second product in the pipeline, Adlea (formerly 4975), has been shown to reduce pain after only a single administration for weeks to months in multiple settings in numerous mid-stage clinical trials for site-specific, moderate-to-severe pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva’s leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: the timing and outcome of our clinical trials and the results of the regulatory approval process for our product candidates. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva’s Form 10-K for the year ended December 31, 2006.

Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement

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