What happened?

On Friday afternoon, Supernus Pharmaceuticals (NASDAQ:SUPN) announced that the U.S. Food and Drug Administration (FDA) had approved Qelbree for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients between the ages of 6 to 17. As a result of this regulatory update, shares of the biopharmaceutical company are rising sharply on Monday and were up by 10.2% as of 1:49 p.m. EDT after jumping by as much as 11.4% earlier in the day.

So what

It hasn't been an easy road for Supernus Pharmaceuticals' attempt to earn approval for Qelbree: The company conducted four phase 3 clinical trials with over 1,000 ADHD patients to demonstrate the safety and efficacy of this medicine. Supernus Pharmaceuticals' hopes for this product were also dealt a severe blow in November 2020 when the FDA rejected an initial application for Qelbree. Thankfully, the healthcare company resubmitted its New Drug Application (NDA) for Qelbree in February, and these efforts have now borne fruit with the medicine finally earning regulatory approval.

Man holding sign that says "FDA Approved."

Image source: Getty Images.

Supernus Pharmaceuticals plans to launch Qelbree on the market in the second quarter. Jack A. Khattar, CEO of Supernus Pharmaceuticals, said the following: 

Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD. Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile.

Now what

While Qelbree is only approved for pediatric patients between the ages of 6 and 17 for now, Supernus Pharmaceuticals recently reported positive results from a phase 3 clinical trial of the medicine on adults. The company plans on submitting a supplemental NDA to the FDA for Qelbree in adult patients in the second half of the year.

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