PDUFA: Oct 19 — Supernus Pharmaceuticals

Supernus Pharmaceuticals [Nasdaq: SUPN] expects an FDA decision under the Prescription Drug User Fee Act (PDUFA) on the approval status of SPN-804, being developed for the treatment of epilepsy.

Supernus Pharmaceuticals is a specialty pharmaceuticals company focused on developing differentiated products for targeted specialty therapeutic areas on its own and in partnership with other pharmaceutical companies. Previously, its key technologies are ProScreen, OptiScreen, Microtrol, Solutrol and EnSoTrol, for bioavailability enhancement and oral controlled release, and AvertSM for reduced-abuse potential. The company’s focus has moved to CNS, with: two lead candidates in epilepsy; a Phase IIb stage for impulsive aggression in ADHD (SPN-810); a phase IIa stage for ADHD (SPN-812); and an IND-filed stage for depression (SPN-809).

SPN-804, is a novel, oral, once-daily, extended-release formulation of oxcarbazepine, which is marketed by Novartis under the name Trileptal. Oxcarbazepine is an active voltage-dependent sodium channel blocker that is effective in treating epilepsy. However the drug is associated with many side effects — such as dizziness, double vision, somnolence, nausea, and vomiting — which has limited its use. Supernus has developed an extended-release, once-daily formation to avoid blood level fluctuation and thus improve patient compliance.

Epilepsy is estimated to affect 50 million worldwide.

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