Supernus Pharmaceuticals (NASDAQ: SUPN) shares are rallying on Wednesday after reporting positive results from its Phase 3 study for SPN-812 in adults with ADHD.
The company said that the treatment met its primary endpoint with “robust statistical significance” and showed efficacy on both hyperactivity/impulsivity and inattention subscales with statistical significance.
The Phase 3 study also met the key secondary efficacy endpoint with statistical significance.
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SON-812 is also currently under review by the US Food and Drug Administration (FDA) for the treatment of patients between six to 17 years old. However, the company was issued a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) to treat patients in this age bracket stating that the application is not ready in its current form.
“These compelling data in adults will be important for our planned sNDA submission to make this treatment option available, if approved by the FDA, to the adult ADHD patient population, which represents approximately half of the total ADHD market in the U.S.,” stated Jack Khattar, President and CEO of Supernus.
Supernus said it will be meeting with the FDA in January to discuss the CRL, after which they plan to submit a new NDA.
Suprernus shares are trading 24.47% higher premarket at $28.03 following Tuesday’s close at $22.52.
