Late yesterday afternoon after U.S. markets closed for trading, Supernus Pharmaceuticals Inc. (SUPN:NASDAQ), which develops and commercializes products used to treat central nervous system (CNS) diseases, announced "positive topline results from a Phase 3 study of SPN-812 in adults (P306) for the treatment of attention deficit hyperactivity disorder (ADHD)."
Supernus Pharmaceuticals indicated that in the Phase 3 Adult ADHD (P306) trial at a daily dosage level of up to 600mg, SPN-812 was well tolerated and met the primary endpoint with robust statistical significance versus placebo. This endpoint was based upon the improvement in ADHD symptoms from baseline to end of study as measured by ADHD Investigator Symptom Rating Scale (AISRS). The company added that SPN-812 also met the key secondary efficacy endpoint in the study identified as the change from baseline of the Clinical Global Impression Severity Scale (CGI-S) at week six. The firm said that the trial enrolled 374 patients in the multicenter clinical trial with participants being given a daily dose of SPN-812 starting with 200mg with flexible dose administration up to 600mg.
The firm advised that a New Drug Application (NDA) for SPN-812 is currently under review by the U.S. Food and Drug Administration (FDA) for use in the treatment of ADHD in pediatric patients ages 6 to 17. The company noted that the FDA issued a Complete Response Letter (CRL) pertaining to the application and that it plans to meet with the FDA in January 2021 to discuss the items outlined in the CRL. The firm stated that if is successful in receiving approval from the FDA for pediatrics uses, it intends to submit a supplemental NDA (sNDA) to the FDA for SPN-812 in adults in H2/21.
Supernus Pharmaceuticals' President and CEO Jack Khattar commented, "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 United States...We now have positive Phase III data proving the efficacy and safety of SPN-812 in a broad range of ADHD patient populations; children 6-11 years old, adolescents 12-17 years old, and adults."
The company explained that SPN-812 is a novel non-stimulant with a unique pharmacological and pharmacokinetic profile and that it believes SPN-812 could be a well-differentiated treatment for ADHD. The firm stated that viloxazine hydrochloride, which is the active ingredient in SPN-812, has been previously marketed in Europe for many years as an antidepressant where it achieved an excellent safety record.
Supernus Pharmaceuticals concentrates its work on creating and marketing products utilized for treating central nervous system (CNS) diseases. The company listed that at present, "it markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy; Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy; APOKYN® (apomorphine hydrochloride injection) for the acute treatment of hypomobility in advanced Parkinson's disease (PD); MYOBLOC® (rimabotulinumtoxinB) for the treatment of cervical dystonia and treatment of chronic sialorrhea in adults; and XADAGO® (safinamide) as an adjunctive treatment to levodopa/carbidopa in PD patients with hypomobility." The firm noted that it is also in the process of developing other candidates to treat CNS indication in several other areas including ADHD; epilepsy, hypomobility in PD and treatment-resistant depression.
Supernus Pharma began the day with a market capitalization of around $1.2 billion with approximately 52.68 million shares outstanding and a short interest of about 10.90%. SUPN shares opened nearly 17% higher today at $26.31 (+$3.79, +16.83%) over yesterday's $22.52 closing price and reached a new 52-week high price this morning of $27.5535. The stock has traded today between $25.19 to $27.5535 per share and is currently trading at $26.35 (+$3.83, +17.01%).
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