Supernus Pharmaceuticals Advances SPN812 into Phase IIa U.S. Clinical Trial for ADHD
Study Measures Safety and Tolerability of Non-Stimulant Therapy for Treatment of ADHD in Adults
SPN812 Represents Second Supernus ADHD Compound to Enter Phase II, Following Positive Phase IIa Results for SPN810
Rockville, MD, July 13, 2010 – Supernus Pharmaceuticals Inc. today announced the initiation of a Phase IIa U.S. clinical trial of its product candidate SPN812 for the treatment of ADHD in adults. The trial is a proof-of-concept, randomized, double-blind, placebo-controlled study in healthy adults aged 18 to 64, inclusive, with ADHD. Supernus expects to enroll 50 subjects in the study at 5 sites across the United States. The primary objective is to measure safety and tolerability, with a secondary measure of efficacy in reducing symptoms of ADHD. SPN812 has previously been marketed outside the United States with a good tolerability and safety profile."We are excited to advance our second ADHD portfolio product into Phase II as we make steady progress across all of our pipeline products," said Jack Khattar, Supernus president and CEO. "Nearly 10 million American adults are estimated to suffer from ADHD, and about 30% of patients do not adequately respond to or cannot tolerate stimulant ADHD treatments. The mechanism of action of SPN812 appears to be promising as a novel treatment of ADHD and we believe it represents a strong alternative to existing ADHD regimens in the United States."
SPN812 is one of three compounds being developed by Supernus to treat patients with ADHD. Supernus previously announced positive results from its Phase IIa proof-of-concept study of SPN810 for the treatment of children with ADHD who exhibit persistent serious conduct problems. That trial, which met the primary endpoints of safety and tolerability, showed statistically significant reduction versus baseline in conduct problems across all doses in children 6 to 12 years of age diagnosed with ADHD. Supernus also is developing SPN811 as a novel stimulant ADHD treatment, and the company expects to initiate a Phase II proof-of-concept trial in 2011.
Attention-deficit-hyperactivity disorder (ADHD) is one of the most common childhood disorders and can continue through adolescence and adulthood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and hyperactivity (over-activity). In the United States, approximately 7.8% of all school-aged children, or about 4.4 million children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of US adults aged 18 to 44 based on results from the National Comorbidity Survey Replication. A report from the market research firm Datamonitor estimates that the adults who have ADHD in the US total almost 10 million persons.
Supernus Pharmaceuticals, Inc. is focused on developing specialty CNS products designed to address unmet medical needs. The company's portfolio is well diversified with its two lead products SPN-804 and Trokesa® for the treatment of epilepsy approaching NDA filings, followed by three products in the ADHD area, SPN810 and SPN812 in Phase II and SPN811 scheduled to enter Phase II in 2011.
The company's extensive expertise in product development is well proven over the past 20 years. Supernus started its operations in December 2005 when it purchased substantially all the assets of Shire Laboratories, Inc. Products using the technologies and expertise of Supernus, and when formerly Shire Laboratories, include: Adderall XR®, Carbatrol®, Equetro® and IntunivTM that are marketed by Shire or its sub-licensees; and Oracea® and Sanctura® XR that are marketed by Galderma and Allergan, respectively.
CONTACT:
Russell "Rip" Wilson
Chief Financial Officer
Supernus Pharmaceuticals, Inc.
Tel: 301 838-2522