New drug - known as Zelrix and NP101 - safety trails results

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New drug - known as Zelrix and NP101 - safety trails results

Post by Tee on Fri Jun 24, 2011 7:13 pm

Data Demonstrate a Low Rate of Triptan-Related Adverse Events Throughout 12 Month Safety Trial

CONSHOHOCKEN, PA, Jun 23, 2011 (MARKETWIRE via COMTEX) -- NuPathe Inc. PATH -0.28% , a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, including neurological and psychiatric disorders, today announced that additional safety data from a 12 month study of its transdermal patch for migraine will be presented at the 15th Congress of the International Headache Society (IHS) this week in Berlin.

The 12 month study (NP101-008) was an open-label trial designed to assess the long-term safety and efficacy of the migraine patch (known as Zelrix and NP101). A total of 183 patients were enrolled and applied at least one migraine patch. More than 2,000 patches were applied during the course of the trial. Top-line results of this 12 month study were announced in October 2010 with additional results presented at the annual meeting of the American Headache Society earlier this month. These data showed that the migraine patch maintained a consistent efficacy and safety profile with repeat use over 12 months. These data also showed that patients exhibited a very low incidence of triptan-related adverse events such as numbness of the extremities and paresthesias or tingling.

The following additional data for the migraine patch showing the percentage of patients with triptan-related adverse events throughout the course of the study will be presented at the IHS Congress.




-- During month one of the study, only 1.6 percent of patients reported
triptan-related adverse events.
-- During months two through 12, no patients reported triptan-related
adverse events.




"Many migraine patients delay or skip their medication because of fear of adverse events, including triptan-related ones, as well as because of migraine-related nausea and vomiting," said study investigator Timothy Smith, MD, RPh, FACP, vice president of research, Mercy Health Research, Center for Innovative Care, Sisters of Mercy Health System, St. Louis, MO. "The efficacy data for headache pain and nausea in this study, combined with the very low incidence of triptan-related adverse events, further demonstrate the potential of NuPathe's migraine patch to address the unmet needs of millions of migraine patients facing these issues."

The additional safety data complement previously announced efficacy data from the study for all migraines treated during the 12 months of the study as measured after two hours of treatment: 58 percent of patients experienced headache pain relief, and 79 percent were nausea free. These results are significant because during a migraine attack many patients suffer from one or more gastrointestinal (GI) issues, including migraine-related nausea or MRN. These GI issues can cause patients to delay or avoid using oral medications and interfere with how the medication is absorbed in the body. Zelrix was well tolerated in this study. The most common adverse events were related to the patch application site and included application site itching (21 percent of patients), application site pain (21 percent), and application site hypersensitivity (6 percent).

http://www.reuters.com/article/2011/06/23/stjude-idUSN1E75M07B20110623
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