FDA Rejects Acorda Epilepsy Drug
The U.S. Food and Drug Administration (FDA) has rejected approval for an epilepsy drug developed by Acorda Therapeutics Inc as a treatment for patients who experience repetitive seizures.
About the Acorda Epilepsy Drug
According to Reuters, the new drug, Plumiaz, is a nasal form of a standard epilepsy drug already on the market and uses diazepam as its active ingredient. Diazepam is most commonly sold as the anti-anxiety tablet Valium.
Plumiaz currently has orphan drug status meaning that, had the drug been approved, Acorda would have a period of marketing exclusivity.
Acorda has not disclosed why the FDA rejected the drug, but the company did say that it plans to resubmit the approval application.
It is currently estimated that 2.8 million Americans suffer from epilepsy, 175,000 of which experience cluster seizures.
Diazepam Side Effects
The following adverse events have been linked to diazepam:
- Completed suicide
- Drug toxicity
- Brain edema