Wrap Matrix products
Levetiracetam, an anti-epileptic with high solubility and very large dose has been developed as a 1000 mg and 1500 mg tablet, and bioequivalent to Keppra. Pivotal pharmacokinetic studies had been completed, and an NDA for this product was filed in 2012-13.
Subsequently, a complete response letter was received from the USFDA. To address FDA's requirements we propose to do one additional Pharmacokinetic study, for which FDA response is positive. We plan to complete this study and submit the response by Q2 FY15.
SPARC owns substantial intellectual property lasting till 2028 for this product. The IP covers composition and dose ranging from about 800 to 1600 mg of Levetiracetam for once-a-day product.
Our market access study in the US reinforces our understanding that pill burden is a key issue for epilepsy patients and some of them are ready to pay higher co-pay to reduce this.
Venlafaxine 300 mg is also developed using Wrap Matrix technology. We filed an NDA in Q4 FY13. We have received a complete response letter in which USFDA has asked for clinical data to establish safety and efficacy of 300 mg dose. Post
response, SPARC conducted a meeting with FDA in February and proposed to provide data from published literature. The current labeling of Venlafaxine ER in US is up to 225 mg and FDA wants data to support safety and efficacy of the 300 mg dose.
Eight controlled release products based on this technology have already been launched in India . They include molecules like Metoprolol (antihypertensive ) & its combinations , Ropinirole , Pramipexole & Bupropion.