Noven Pharmaceuticals, Inc announced that the US Food and Drug Administration (FDA) has approved Stavzor (valproic acid delayed release capsules) in 125 mg, 250 mg and 500 mg strengths. Stavzor is approved for the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures, and for prophylaxis of migraine headaches.
The product will be marketed and sold by Noven Therapeutics, LLC, Noven's specialty pharmaceutical subsidiary, and is expected to be available in pharmacies in the second half of August.
Stavzor soft gel capsules are small (up to 40 per cent smaller than Depakote and Depakote ER tablets at the 500 mg dosage strength) and easy to swallow, with an advanced enteric technology designed to reduce reflux and gastric irritability. Banner Pharmacaps Inc, Noven's development partner for this product, developed Stavzor using its EnteriCare enteric soft gelatin capsule delivery system, and submitted the Stavzor New Drug Application to the FDA.
"Valproate, the active ingredient in Stavzor, is recommended by the American Psychiatric Association as a first-line therapy for patients living with bipolar disorder and experiencing manic episodes," said Dr. Miguel Martelli, a psychiatrist in private practice in Georgia. "The small size and soft gel capsule formulation of Stavzor should make this new product easy to swallow, which in my experience is critical to helping valproate patients start - and stay on - their medication."
"Our research indicates that valproate patients would prefer a small, soft gel capsule - like Stavzor - that is easy to swallow," said Anthony Venditti, Noven's Vice President - Marketing & Sales. "In a recent survey of 400 valproate users, more than two-thirds reported difficulty swallowing their other valproate medications, and 85 per cent said they would have preferred a small soft gel capsule had it been available when initiating therapy. These are some of the patients who we expect to help with the launch of Stavzor," said Anthony.
"The approval of Stavzor is an important development for patients who use valproate products and for our company," said Peter Brandt, Noven's President and Chief Executive Officer. "For patients, it represents a new, easy-to-swallow treatment option that may help with compliance. For Noven, it represents a significant step toward our goal of establishing Noven as a high-growth specialty pharmaceutical company," explained Peter.