The Food and Drug Administration has set a hearing for Aug. 4 to discuss Pozen’s proposed migraine drug MT 100 and possible side effects.
Pozen said Wednesday that the meeting will focus on the potential risk of a neurological disorder called tardive dyskinesia affecting users of MT-100.
The meeting will be conducted by the FDA’s Peripheral and Central Nervous Systems Drug Advisory Committee.
Pozen had appealed FDA rejection of the drug.
This action came as a result of a series of meetings held between the two parties late last year.
“The FDA stated in a recent memo that it is possible that MT 100 may not be approvable if the benefits of the drug do not, in FDA’s opinion, outweigh the risks of MT 100, including the risk of tardive dyskinesia, even if FDA eventually determines that MT 100 meets the efficacy requirements for a combination migraine agent,” Pozen said in a statement issued in December.
The FDA issued a non-approvable letter to Pozen in May of 2004.
“Given the number of patients exposed to MT100 for at least one year in your database, the absence of any detected cases is consistent with a true rate of TD [tardive dyskinesia ] of about 1%, an unacceptably high risk in the absence of any demonstrated advantage of the product,” the FDA wrote in its non-approvable letter for MT-100, according to a wire service report.
The rejection triggered a massive selloff of Pozen (Nasdaq: POZN) stock and also led to a series of class-action lawsuits.
Pozen stock closed at $7.88. Before the rejection letter the stock was selling at better than $17 a share, based in part on a lucrative drug development deal signed with GSK. Its 52-week low is $3.50.
MT 100 is also being reviewed in Great Britain.
Pozen: www.Pozen.com
