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Cancer, Epilepsy, and Opioid-Dependence Drugs Set for FDA Review
Tivozanib for Renal Cancer:
The FDA’s Oncologic Drugs Advisory Committee has agreed to review the new drug application (NDA) for tivozanib (Aveo Oncology/Astellas Pharma) for the treatment of patients with advanced renal cell carcinoma (RCC) during its meeting on May 2, 2013.
The NDA includes results from the global phase III TIVO-1 (TIvozanib Versus SOrafenib in 1st-Line Advanced RCC) trial — a randomized pivotal study that evaluated the efficacy and safety of tivozanib compared with that of sorafenib (Nexavar, Onyx Pharmaceuticals/Bayer HealthCare), an approved targeted agent, in 517 patients with advanced RCC.
Tivozanib is an oral, once-daily investigational tyrosine kinase inhibitor.
Eslicarbazepine for Epilepsy-Related Seizures:
The FDA has accepted for review the resubmission of an NDA for Stedesa (eslicarbazepine acetate, Sunovion Pharmaceuticals) for use as a once-daily adjunctive therapy in the treatment of partial-onset seizures in adults (aged 18 years and older) with epilepsy.
The NDA for Stedesa is supported by clinical data from three 12-week, phase III, randomized, double-blind, placebo-controlled maintenance trials, which included more than 1,300 patients with partial-onset seizures. Treatment with Stedesa provided statistically significant reductions in standardized seizure frequency when used as adjunctive therapy.
Stedesa (eslicarbazepine acetate) is an investigational voltage-gated sodium and T-type calcium channel blocker. Eslicarbazepine is currently marketed in Europe under the trade name Zebinix.
Buprenorphine Implant for Opioid Dependence:
The FDA’s Psychopharmacologic Drugs Advisory Committee is scheduled to review the NDA for Probuphine (buprenorphine implant, Titan Pharmaceuticals) for the maintenance treatment of adult patients with opioid dependence on March 21, 2013.
Probuphine is an investigational subdermal implant capable of delivering continuous blood levels of buprenorphine for 6 months following a single treatment. Buprenorphine, an approved agent for the treatment of opioid dependence, is currently available in the form of daily-dosed sublingual tablets and film formulations.
The ProNeura continuous drug-delivery system consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, usually in the upper arm in a simple office procedure, and is removed in a similar manner at the end of the treatment period. The drug substance is released slowly and continuously through the process of dissolution, resulting in a steady rate of release similar to that of intravenous administration.