december, 2018

01decAll Day31SUPN PDUFA Oxtellar XR

Event Details

Oxtellar XR for epilepsy. Expanded label to include monotherapy treatment. PDUFA date by the end of December 2018 but no hard date given.

“We delivered another strong quarter of growth in net product sales for both Trokendi XR and Oxtellar XR, driven by the strong underlying demand for both products,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “We are executing well against our commercial strategy and continue to build on the momentum established last year.”

During April 2018, the U.S. Food and Drug Administration (FDA) accepted for review the Company’s efficacy supplement requesting expansion of the current indication for Oxtellar XR to include monotherapy treatment of partial seizures of epilepsy for adults and for children 6–17 years. Oxtellar XR is currently indicated as adjunctive therapy for treatment of partial seizures of epilepsy for adults and for children 6–17 years. A decision by the FDA on the Company’s supplement is expected by the end of December 2018.

Mr. Khattar added, “We are excited about this potential label expansion for Oxtellar XR and believe it will allow us to maximize the potential of the product in epilepsy.”

Progress of Product Pipeline

The Company continues to expect that data will be available from the Phase III programs for SPN-812 and SPN-810 by the first quarter of 2019.

  • Overall enrollment in the four Phase III trials for SPN-812, a novel non-stimulant for the treatment of ADHD, is approximately 61% complete. The program consists of four three-arm, placebo-controlled trials; two of which are pediatric trials and two of which are adolescent trials.
  • Enrollment continues in both Phase III trials (P301 and P302) for SPN-810, currently in development for Impulsive Aggression (IA) in pediatric patients who have ADHD. Enrollment in P301 and P302 is approximately 86% and 71% complete, respectively. In addition, the Company expects that a Phase III trial for SPN-810 treating IA in adolescents who have ADHD to start mid-2018.

Regarding Oxtellar XR, the investigator-sponsored trial in bipolar disorder is expected to complete enrollment by year end 2018.

Supernus Pharmaceuticals News


december 1 (Saturday) - 31 (Monday)

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