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Supernus Pharma's late-stage study supporting IA candidate SPN-810 to continue as planned, lower dose eliminated

  • An interim analysis by an independent statistician concludes that the first of two Phase 3 clinical trials assessing Supernus Pharmaceuticals' (NASDAQ:SUPN) SPN-810 for the treatment of impulsive aggression (IA) in children 6 - 12 years old should continue as planned, randomizing participants to the 36 mg dose arm or placebo. The lower dose of 18 mg will be terminated.
  • Enrollment will continue through mid-2018.
  • SPN-810 (molindone hydrochloride) was originally marketed under the brand name Moban for schizophrenia by Endo Pharmaceuticals, who ceased supplying the product in January 2010. A generic version is currently being sold in the U.S. by privately held CorePharma.
  • The company will host a conference call today at 5:00 pm ET to discuss the data.
  • Trading in SUPN, currently suspended, will resume at 4:30 pm ET.

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