The FDA has agreed to give Pozen another review for its drug MT-100, which is intended to be a treatment for migraine headaches.
The FDA is concerned that the drug can cause tardive dyskinesia, which is involuntary movements of the tongue, lips, facial and other muscles.
The review by an advisory committee will take place in May.
“This action came as a result of a series of meetings held between the two parties. 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.
The FDA issued a non-approvable letter to Pozen in May.
MT 100 is also being reviewed in Great Britain.
Pozen: www.Pozen.com
