Supernus Pharmaceuticals, Inc. (SUPN) recently provided information on its agreement with Patheon Inc. (PNHNF) for the manufacture, formulation, development and supply of commercial-grade quantities of oxcarbazepine, the active pharmaceutical ingredient in Supernus’ Oxtellar XR, in the US.
As per the terms of the commercial supply agreement, Patheon will manufacture (including processing, packaging and labeling) oxcarbazepine at its facility.
Supernus will provide Patheon with all relevant materials required for manufacturing the product.
Oxtellar XR is a novel once-daily extended release formulation of oxcarbazepine. Oxtellar XR is an antiepileptic drug (AED) indicated for adjunctive therapy for the treatment of partial seizures in adults and in children 6 to 17 years of age.
Oxtellar XR was approved by the US Food and Drug Administration (:FDA) in Oct 2012. In Nov 2012, Supernus received three years of marketing exclusivity from the FDA. On Feb 4, 2013, Oxtellar XR was launched in the US. Supernus’ 75 person sales force has started promoting the product.
The launch of Oxtellar XR is a significant milestone for the company. Supernus’ main area of focus is the development of products for central nervous system (CNS) disorders. The company’s pipeline includes SPN-810 (completed phase IIb) for the potential treatment of impulsive aggression in attention deficit hyperactivity disorder (:ADHD) patients and SPN-812 (completed phase IIa) for ADHD.
In Nov 2012, the company had announced encouraging top-line results from a phase IIb study on SPN-810, across three doses. The company plans to advance the candidate into phase III trials and will meet the FDA to discuss the trial design and protocol for the same.
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