Rockville Pharmaceutical Company Wins FDA Approval for Anti-Epilepsy Drug

Supernus shares jump on news; Company to launch drug sales early next year.


An anti-epilepsy drug manufactured by Supernus Pharmaceuticals, Inc. received approval from the Food and Drug Administration, the Rockville-based company announced Monday.

Oxtellar XR is a formulation of the anti-epileptic drug oxcarbazepine and is intended to treat seizures in children age 6 to 17, according to a news release from the company. It will be marketed in once-a-day extended release tablets beginning early next year, the release said.

"This approval represents a significant milestone for Supernus in realizing its vision of becoming a leading [central nervous system] specialty pharmaceutical company,” Jack Khattar, CEO, president and director of Supernus, said in the release. “We will now focus on completing the build-out of our commercial organization including, hiring, training and deploying our field sales force to launch Oxtellar XR in the first quarter of 2013.”

Supernus (NASDAQ: SUPN) shares jumped more than 10 percent to $14.30 in the hours after the announcement Monday morning, USA Today reported.

The stock closed at $12.91 a share on Monday, NASDAQ reported.

Shares were trading at $12.17 at 3 p.m. on Tuesday, down from a high of $13.08 earlier in the day, according to NASDAQ.

Oxtellar XR is the second anti-epilepsy drug by Supernus to receive FDA approval since the company’s initial public offering in May. The company received tentative approval of Trokendi XR in June.

Supernus shares have traded between $4.30 and $16.68 since the IPO, according to NASDAQ.

The FDA approval, granted Friday, included a waiver of a pediatric study requirement for ages birth to one month, the release said. It also deferred preclinical testing of the drug’s use by children up to 6 years old until 2016, with clinical assessments due in 2021.


More »
Got a question? Something on your mind? Talk to your community, directly.
Note Article
Just a short thought to get the word out quickly about anything in your neighborhood.
Share something with your neighbors.What's on your mind?What's on your mind?Make an announcement, speak your mind, or sell somethingPost something
See more »