AAPM
The E-newsletter of the American Academy of Pain Management

Product News and Clinical Trial Results

APP Pharmaceuticals receives approval for Sumatriptan Succinate Injection, USP
October 9, 2009 Source: Fresenius Kabi AG
APP Pharmaceuticals, Inc. announced today that it has received approval from the U.S. Food and Drug Administration to market Sumatriptan Succinate Injection, USP, in two dosage strengths. Sumatriptan Succinate Injection, the therapeutic equivalent to Imitrex®, is a vascular headache suppressant indicated for the acute treatment of migraine attacks with or without aura and the acute treatment of cluster headache episodes.
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AVANIR Pharmaceuticals presents Zenvia Phase III results in multiple sclerosis patient population at Controversies in Neurology congress
October 9, 2009 Source: AVANIR
AVANIR Pharmaceuticals announced today that Zenvia 30/10 mg dose met the primary endpoint in the subset of patients with underlying multiple sclerosis (MS) by significantly reducing pseudobulbar affect episode rates compared to placebo. Zenvia 30/10 mg also demonstrated relief of MS-related pain in the subset of MS patients with moderate-to-severe pain.
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BioDelivery Sciences and Meda launch ONSOLIS (fentanyl buccal soluble film)
October 8, 2009 Source: BioDelivery Sciences International, Inc
BioDelivery Sciences International Inc. announced that its commercial partner Meda will launch the FDA-approved ONSOLIS (fentanyl buccal soluble film) next week for the management of breakthrough pain in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
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Nutra Pharma announces Nyloxin Rx, a prescription analgesic for the treatment of severe (Stage 3) chronic pain
October 7, 2009 Source: Nutra Pharma Corp
Nutra Pharma Corp. has announced today its intent to launch a prescription analgesic, Nyloxin Rx, for the treatment of severe (Stage 3) chronic pain. Nyloxin Rx uses a novel mechanism from cobra venom peptides for treating pain.
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FDA accepts ProStrakan's Abstral NDA filing for review
October 6, 2009 Source: Orexo
Orexo AB today confirmed that its partner, ProStrakan Group plc, has announced that the New Drug Application filing for Abstral has been accepted for review by the US Food and Drug Administration. Abstral is a new, rapidly disintegrating, sublingual formulation of fentanyl, a long-established opioid used for the management of episodes of breakthrough pain experienced by cancer patients who are already receiving opioid analgesics for their chronic pain. ProStrakan plans to launch Abstral in the US in the second half of 2010.
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Transdel Pharmaceuticals announces positive Phase 3 study results for lead topical pain drug Ketotransdel(R)
October 6, 2009 Source: Transdel Pharmaceuticals, Inc.
Transdel Pharmaceuticals, Inc. today announced positive top-line clinical results for its lead pain drug Ketotransdel® in a Phase 3 trial which evaluated the efficacy and safety of the drug in acute soft tissue injuries of the upper and lower extremities. Ketotransdel® is comprised of a transdermal formulation of ketoprofen, an NSAID, and the Company's innovative proprietary Transdel(TM) drug delivery system.
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Depomed, Inc. announces positive top-line results from Phase 3 clinical trial of DM-1796 in postherpetic neuralgia
October 5, 2009 Source: Depomed, Inc
Depomed, Inc. today announced top-line results from a Phase 3 clinical trial demonstrating DM-1796 achieved a statistically significant reduction in pain associated with postherpetic neuralgia (PHN) versus placebo using the baseline observation carried forward method required by the FDA. DM-1796 is an investigational extended release, once-daily tablet formulation of gabapentin for the treatment of PHN.
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Pharma announces manufacturing release of Cobroxin, a treatment for chronic pain
October 2, 2009 Source: Nutra Pharma Corp
Nutra Pharma Corp announced today that it has completed manufacturing the first commercial batch of Cobroxin and has successfully released it for final distribution. Cobroxin is the first OTC pain reliever clinically proven to treat Stage 2 (moderate to severe) chronic pain. The drug will be available as an oral spray for treating lower back pain, migraines, neck aches, shoulder pain, cramps and neuralgia and as a topical gel for treating joint pain and pain associated with repetitive stress and arthritis.
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NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA
September 25, 2009 Source: Nicox
NicOx S.A. today announced that a New Drug Application for naproxcinod has been submitted to the United States Food and Drug Administration. Naproxcinod, the first in a new class of anti- inflammatory agents known as cyclooxygenase-inhibiting nitric oxide donators, is indicated for the relief of the signs and symptoms of osteoarthritis.
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J&J recalls some infant's, children's Tylenol lots
September 24, 2009 Source: Reuters
Johnson & Johnson said on Thursday it is recalling some lots of infants' and children's Tylenol because of a possible bacterial contamination of the popular pain and fever treatment. The company identified 21 varieties of the products, and 57 different lot numbers, affected by the recall.
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FDA Advisory Committee hears presentations and public comment on EXALGO extended-release tablets
September 24, 2009 Source: Neuromed
Today, the U.S. Food and Drug Administration heard presentations and public testimony and discussed the New Drug Application submitted by Neuromed, which is seeking FDA approval for EXALGOTM (hydromorphone HCl extended release) tablets. If approved, EXALGOTM will offer around-the-clock relief to opioid tolerant patients with moderate to severe pain.
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US advisers back plan to monitor Covidien pain drug
September 23, 2009 Source: Reuters
A U.S. panel of medical experts backed Neuromed Pharmaceuticals Inc and Covidien's plan to limit potential abuse with their powerful, once-a-day painkiller Exalgo, saying the drug was very effective but could easily be misused. Neuromed is currently seeking U.S. FDA approval of its opioid drug for patients who no longer get relief with other similar medications.
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King announces commercial availability of EMBEDA
September 21, 2009 Source: King Pharmaceuticals, Inc.
King Pharmaceuticals today announced the first commercial availability for EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, a long-acting Schedule II opioid analgesic for the management of moderate to severe pain. EMBEDA is the first U.S. FDA approved long-acting opioid designed to reduce drug liking and euphoria when tampered with by crushing or chewing.
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QualityMetric pairs Pain Impact Questionnaire(TM) (PIQ-6(TM)) and SF-12v2(R) Health Survey to measure health status and pain simultaneously
September 21 2009 Source: QualityMetric Incorporated
Today, QualityMetric announced the availability of the SF-12v2(R) Health Survey Pain Enhanced, a combination of the Pain Impact Questionnaire(TM) (PIQ-6(TM)) and SF-12v2(R) Health Survey. The combined tool allows for a more comprehensive and targeted care that was not previously available through one tool.
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Zelrix, a novel transdermal patch for migraine, found to provide rapid, consistent, and sustained relief for migraine sufferers in Phase III trial
September 10, 2009 Source: NuPathe Inc.
NuPathe Inc. today announced data from the pivotal Phase III trial of Zelrix™, a novel transdermal patch in clinical development for the treatment of acute migraine. In a trial of 530 adults, Zelrix demonstrated a statistically significant improvement compared to placebo for pain freedom at two hours after patch application (18 percent vs. 9 percent).
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Data Show Patients With Chronic Low Back Pain Maintained Pain Reduction on Cymbalta(R)
September 11, 2009 Source: Eli Lilly and Co
New data showed that patients with chronic low back pain on Cymbalta (duloxetine HCl) maintained reductions in pain for 41 weeks. Of the total of 181 patients taking duloxetine HCl 60 mg or 120 mg once daily, maintenance of effect was assessed in 58 duloxetine patients. These 58 patients had experienced at least 30 percent pain reduction from baseline during the 13-week, placebo-controlled acute phase of the study.
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Pain Expert Discusses New Drug Delivery Technology And Safety Program Surrounding Novel Pain Treatment
September 11, 2009 Source: Biodelivery Sciences International Inc.
While there are two breakthrough cancer pain products containing fentanyl already on the market—one a lozenge, the other a buccal tablet—the delivery system of ONSOLIS makes it unique. ONSOLIS uses the BioErodible MucoAdhesive (BEMA®) drug delivery technology that consists of a small, water-soluble, polymer film that is applied to the inside of the cheek (buccal mucosa). The fentanyl buccal soluble film adheres to the buccal mucosa in seconds, dissolves within fifteen to thirty minutes, and is designed to optimize delivery of fentanyl across the buccal mucosa.
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Allergan's Botox reduces migraine headache days
September 10, 2009 Source: Allergan Inc
Botox significantly reduced the number of headache days for adults suffering from chronic migraines, according to two late-stage trials.In one 679-patient trial, patients injected with Botox had headaches on 7.8 fewer days each month, compared with a drop of 6.4 days in the placebo group. In a second trial involving 705 migraine sufferers, Botox-treated patients had nine fewer headache days compared with a drop of 6.7 days for the placebo group.
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MAP Pharma: migraine drug helps hard-to-treat groups
September 10, 2009 Source: MAP Pharmaceuticals Inc
An study of the inhaled migraine drug being developed by MAP Pharmaceuticals Inc. showed that the drug was effective in treating a broad spectrum of migraine, including migraine subpopulations that are often resistant to current therapies.
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