Phase 2 clinical study results for acute migraine
By Live Dr - Sun Oct 31, 7:43 pm
NeurAxon Announces NXN-188 Phase 2 Data Demonstrating Efficacy in Acute Migraine
– Data Presented at the European Headache and Migraine Trust International Congress –
Waltham, MA. October 31, 2010 – 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 study was Pain Relief at 2 hours: although NXN-188 did not reach significance at this time point (p=0.0801), a statistically significant response was reported from 4 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. In the clinically important end point of Total Migraine Freedom – complete absence of pain, nausea, photophobia (light sensitivity), and phonophobia (sound sensitivity) – statistical significance was reached at 1 hour (p=0.0284), and benefit was maintained throughout the study period.
NXN-188 demonstrated efficacy compared to placebo on the additional key measures of Pain Freedom, Sustained Pain Freedom, and Use of Rescue Medication. Rescue medication is frequently required with current migraine treatments, but in this study the use of rescue medication following NXN-188 was nearly half that for placebo (p=0.0122). NXN-188 was well tolerated with no serious adverse events and no triptan-like adverse events were reported.
Professor Peter Goadsby, M.D., Ph.D., Director of the UCSF Headache Center commented, “NXN-188 represents a truly innovative approach to medicine design by incorporating two mechanisms of action against two specific targets in migraine in one treatment. It is an exciting development that doctors and patients can look forward to hearing more about soon.”
“Migraine is a debilitating illness that severely impacts patients’ lives, and current therapies often fall short of expectations, providing either inadequate or temporary relief from migraine symptoms. We set very high hurdles for NXN-188 in Study 204, exploring not only the standard measures, but several newer and more challenging endpoints. In this study we evaluated Total Migraine Freedom, the complete absence of all pain, nausea, and sensitivity to light and sound, and found that a significant proportion of patients receiving NXN-188 reported that all of their migraine symptoms had abated,” said NeurAxon Chief Medical Officer, Robert Medve, M.D. “NXN-188 shows benefits across multiple measures and multiple time points as early as 30 minutes after dosing, and we believe that it has the potential to make a meaningful difference in patients’ lives.”
About NXN-188 and Study 204
Study 204 was a randomized, double-blind, placebo-controlled, two arm study of a single oral dose of 600 mg of NXN-188 for the treatment of moderate to severe acute migraine headache without aura. In the trial, 86 patients received NXN-188, and 88 patients received placebo. These data were discussed during an oral presentation by Dr. Robert Medve on October 31, 2010 at the European Headache and Migraine Trust International Conference in Nice, France.
Migraine affects about 15% of the population in Europe and the U.S. and is characterized by intense pain, nausea, and other disabling symptoms. Migraine attacks typically last up to several days, and the financial burden in the U.S. alone is estimated at 17 billion dollars. Current treatments are limited as they are not effective or consistent for all migraine sufferers, and the effect may dissipate before the migraine attack ends, necessitating the use of rescue medications. Current therapies cause a range of side effects including cardiovascular effects, which result in their being contraindicated in some patients.
About NeurAxon, Inc.
NeurAxon, Inc. (www.neuraxon.com) discovers and develops next-generation pain therapeutics focused on its first-in-class selective inhibitors of neuronal nitric oxide synthase (nNOS), an enzyme involved in modulating pain and central nervous system neuronal sensitization.