Endo receives complete response letter for crush-resistant Opana ER
CHADDS FORD, Pa. — The Food and Drug Administration declined to approve Endo Pharmaceuticals’ regulatory application for a painkiller designed to thwart drug abusers, Endo said Friday.
The drug maker announced that the FDA had given it a complete response letter for its application for a crush-resistant formulation of Opana ER (oxymorphone hydrochloride). The company did not specify the reason for the letter, but said the agency had not requested additional clinical studies. A complete response letter means that the FDA has completed its review of a regulatory application, but questions remain that preclude final approval.
“As a result of ongoing discussions with the FDA, we have begun to address the issue from the complete response letter and will work closely with the agency to finalize our response,” Endo EVP research and development Ivan Gergel said.
Gergel said the company planned to respond to the FDA by mid-year and would expect the review to take six months.
Watson’s generic Fentora gets FDA approval
MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related pain, Watson said Monday.
Watson announced the approval of fentanyl buccal tablets in the 0.1-mg, 0.2-mg, 0.6-mg and 0.8-mg strengths.
The drug, used to treat breakthrough pain in patients with cancer, is a generic version of Cephalon’s Fentora, which had sales of around $179 million during the 12-month period ended in November, according to IMS Health. Breakthrough pain refers to flashes of pain that can’t be controlled through normal painkillers.
As the first company to file for approval of a generic version of the drug, Watson is legally entitled to 180 days’ market exclusivity in which to compete directly with the branded version.
Abstral OKed as breakthrough pain treatment for cancer patients
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating pain in cancer patients, the agency said Friday.
The FDA announced the approval of ProStrakan’s Abstral (fentanyl) transmucosal tablets for the management of pain that appears suddenly for short periods and is not alleviated by a patient’s normal pain-management plan, also known as breakthrough pain. The tablets are designed for administration on the soft surfaces of the mouth, including inside the cheek, gums and tongue, as well as the nasal passages or the throat.
“This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain,” FDA Office of New Drugs director John Jenkins said.
The drug will have a Risk Evaluation and Mitigation Strategy, or REMS program, designed to minimize the risk of misuse, abuse, addiction and overdose, the FDA said.