NeurAxon, Inc., announced today Phase 2 clinical study results for NXN-188, a novel, first-in-class treatment with the potential to raise the current standard of care in acute migraine. NXN-188 is a dual action new chemical entity which incorporates a novel mechanism, selective inhibition of neuronal Nitric Oxide Synthase (nNOS), as well as 5-HT1B/1D activation - the mechanism of triptans, the largest class of migraine drugs. NXN-188 was designed to provide a rapid, robust and sustained therapeutic effect. The primary endpoint in this investigation (Study 204) was Pain Relief at two hours: although NXN-188 did not reach significance at this time point (p=0.0801), a statistically significant response was reported from four through 24 hours. Patients in Study 204 reported Pain Relief as early as 30 minutes after dosing, and relief was sustained across the migraine episode.
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) reported successful results from a thorough QT trial of its investigational LEVADEX™ orally inhaled migraine therapy. The trial evaluated the potential of a supra-therapeutic dose to cause an increase in the QT interval. Results of the trial showed that a supra-therapeutic dose of LEVADEX does not increase QTc intervals. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine. "We are pleased that these results support our previous findings of cardiac safety from our long term open label and pharmacodynamics trials, " said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "We continue to anticipate submitting our NDA in the first half of 2011.
Nautilus Neurosciences And Tribute Pharmaceuticals Announce Exclusive Canadian License For CAMBIA trade; diclofenac Potassium For Oral Solution
Nautilus Neurosciences, Inc., a neurology-focused specialty pharmaceutical company, and Tribute Pharmaceuticals, a privately-held Canadian specialty pharmaceutical company, announced today their exclusive license agreement for the commercialization of CAMBIA ™ (diclofenac potassium for oral solution) in Canada. CAMBIA™ is approved in the United States for the acute treatment of migraine with or without aura and was launched in the United States in June 2010. "Canada is an important pharmaceutical market and opportunity for CAMBIA, " said James Fares, Chairman and CEO, of Nautilus Neurosciences. "The management team at Tribute Pharmaceuticals has a wealth of experience in developing, launching and successfully commercializing new products in Canada. This partnership along with recent developments in the US has significantly enhanced our ability to market CAMBIA™
Scientists have identified a mysterious culprit that threatens headaches, stuffy noses, skin rash and other allergy symptoms when more than 500 million people worldwide drink wine. The discovery could help winemakers in developing the first low allergenic vintages - reds and whites with less potential to trigger allergy symptoms, they say. The new study appears in ACS' monthly Journal of Proteome Research. Giuseppe Palmisano and colleagues note growing concern about the potential of certain ingredients in red and white to cause allergy-like symptoms that range from stuffed up noses to headaches to difficulty breathing. So-called wine allergies occur in an estimated 8 percent of people worldwide. Only 1 percent of those involve sulfites, sulfur-containing substances that winemakers add to wine to prevent spoilage and also occur naturally.
Positive Results Announced Of Phase II Clinical Trial Of Dolorac R Nasal Solution For Chronic Migraine
Winston Pharmaceuticals, Inc. ("Winston"), a specialty pharmaceutical company focused on developing and commercializing novel pain management therapies, announced the results of its Phase II study on its patented Dolorac® Nasal Solution (doxepin 0.4%) for prophylaxis of chronic migraine ("CM") at the Lazard Capital Markets 7th Annual Healthcare Conference in New York. In the 210 patient Phase II double-blind, vehicle-controlled, multi-center study on patients with â 180 headache days per year, twice-daily administration of Dolorac was significantly more effective than control in improving the primary efficacy variables of Headache Duration and Patient Global Satisfaction (P=0.0013 and P=0.0002, respectively). Winston expects to initiate two Phase III pivotal studies, each enrolling 300-350 patients with CM in Q2 2011.