Acorda’s ($ACOR) three-year comeback effort on the epilepsy treatment Plumiaz has ended in failure. One of three studies the company mounted to win over the FDA after a 2013 rejection failed to match a comparator treatment, and the biotech says it’s shuttering the program for the nasal spray formulation for diazepam.
Plumiaz was one of the most advanced R&D efforts at Acorda. And while it was considered less potentially lucrative than the inhaled levodopa therapy CVT-301 ($500 million peak sales estimate by the company) and tozadenant ($400 million peak), the biotech had made it a key part of its $1 billion-plus plan to boost revenue by a blockbuster measure of success.
The problem with Plumiaz was that it failed to measure up to a bioequivalence standard for Diastat (diazepam) rectal gel, which was needed to refile the New Drug Application. “Specifically,” the company added in a statement, “the data demonstrated unexpectedly lower nasal mucosa absorption of diazepam in persons with epilepsy compared to studies in healthy volunteers.”
The drug was designed to help epileptics who were experiencing an increased rate of seizures, known as seizure clusters. If the program had been successful, Acorda was planning to refile the NDA in early 2017.
Ardsley, NY-based Acorda has seen its stock under considerable pressure during H1, with analysts grumbling about rising R&D costs and alarmed by a patent challenge from Kyle Bass aimed at Ampyra, the MS drug franchise that pays the bills at the company.
“We are very disappointed by this outcome, and for those in the epilepsy community who experience seizure clusters,” noted CEO Ron Cohen in a statement. “We will continue to focus on development of our other high potential pipeline programs, including CVT-301 and tozadenant for Parkinson’s disease, and dalfampridine for post-stroke walking difficulty.”
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