Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as such developments impact the share price of the concerned companies. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and finally, a response from the regulatory agency regarding the approval status.
Late last week, Supernus Pharmaceuticals, Inc. (SUPN) announced that its attention deficit hyperactivity disorder (ADHD) candidate, SPN-810 has received Fast track status in the U.S. The company is evaluating SPN-810 for the treatment of impulsive aggression in patients suffering from ADHD.
Notably, the FDA grants Fast track designation to candidates being developed for the treatment of serious conditions, based on clinical or non-clinical data suggesting that they might be beneficial in such cases.
The Fast track status will allow Supernus to interact with the FDA more frequently and make a rolling submission for SPN-810’s approval (which will lead to the submission of the marketing application in parts, as and when data is available). Moreover, SPN-810 might become eligible for an expedited review by the FDA.
Supernus intends to initiate dosing of patients in a phase III study on SPN-810, under the FDA’s Special Protocol Assessment program, for the treatment of impulsive aggression in ADHD patients in 2015. Importantly, SPN-810 is a key candidate in Supernus’ pipeline.
Additionally, Supernus is developing SPN-812 for the treatment of ADHD.
The ADHD market is currently dominated by companies like Shire (SHPG). Some drugs approved for this indication include Vyvanse, Adderall XR, Intuniv and Equasym XL.
We are pleased with Supernus’ efforts to develop its pipeline. The Fast track status comes as a boost for the development process of SPN-810.