Supernus Pharmaceuticals, Inc. ( SUPN Quick Quote SUPN - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA) for its attention-deficit hyperactivity disorder (ADHD) drug, Qelbree (viloxazine extended-release capsules). The sNDA is seeking label expansion of the drug as a potential treatment of adult ADHD patients.
The FDA will provide its decision related to the potential approval of the sNDA by Apr 29, 2022.
Qelbree received its
first FDA approval in April 2021 as a treatment for ADHD in pediatric patients 6 to 17 years of age.
The latest sNDA was filed based on data from a phase III study, completed in December 2020, which evaluated the drug in adult ADHD patients. The data from the study showed that treatment with Qelbree achieved statistically significant improvement in the symptoms of ADHD from baseline compared to placebo. The improvement in ADHD symptoms was the study’s primary endpoint and was measured on the ADHD Investigator Symptom Rating Scale.
The study also met its key secondary efficacy endpoint of change in the severity of illness. The improvement in severity from baseline was of statistical significance versus placebo as measured by the Clinical Global Impression – Severity of Illness Scale at week 6. The drug was well tolerated in study participants.
The launch uptake of Qelbree in pediatric patients during the second quarter remains on track with management’s expectation, garnering sales of $0.3 million in the period. The company believes that a potential approval to the label expansion of Qelbree from the FDA will provide a significant opportunity as it estimates that there are approximately 10 million adults in the United States suffering from ADHD.
Although a potential approval to Qelbree for adult patients is likely to drive prospects, competition is stiff in the ADHD space from Adderall XR,
Johnson & Johnson’s ( JNJ Quick Quote JNJ - Free Report) Concerta (methylphenidate), and Takeda’s ( TAK Quick Quote TAK - Free Report) Vyvanse, among others.
Shares of Supernus have gained 10% so far this year against the
industry’s decrease of 7.8%. Image Source: Zacks Investment Research
We note that the company has a strong portfolio of central nervous system (CNS) disorder drugs. Apart from ADHD, the company’s drugs target patients with epilepsy, Parkinson’s disease, cervical dystonia and sialorrhea. The company boosted its commercial portfolio with acquisition of three CNS drugs from a privately-held pharmaceutical company, US WorldMeds Partners, in April 2020.
The company is also developing three pipeline candidates — SPN-830, SPN-820 and SPN-817 — for treating Parkinson’s disease, epilepsy, and treatment-resistant depression, respectively.
Zacks Rank & Stock to Consider
Supernus currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare space is
Repligen Corp. ( RGEN Quick Quote RGEN - Free Report) , which currently carries a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Earnings estimates for Repligen have moved up 22.1% for 2021 and 18% for 2020 in the past 60 days. The stock has gained 50.6% so far this year.