Transcept announces PDUFA action date for Intermezzo
POINT RICHMOND, Calif. — Transcept announced Monday that the Food and Drug Administration has classified the drug maker’s insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.
Transcept resubmitted its new drug application for Intermezzo (zolpidem tartrate) on Jan. 18 after receiving a complete response letter from the FDA in October 2009. The drug maker said for the completion of the NDA review, the FDA set the PDUFA action date for July 14.
Intermezzo is a pill placed under the tongue for treating patients who awake in the middle of the night and have difficulty falling asleep again.
NACDS files legal brief in case concerning military Tricare program
ALEXANDRIA, Va. — Concerns that contracting rules affecting healthcare providers that service Tricare beneficiaries could extend to retail pharmacies has prompted the country’s largest chain pharmacy lobby to file a friend-of-the-court brief in a lawsuit over the regulations.
The National Association of Chain Drug Stores filed an amicus curiae brief in support of the defendant in the case, Office of Federal Contract Compliance Programs, U.S. Department of Labor v. Florida Hospital of Orlando.
The hospital is appealing a decision by a DoL administrative law judge’s decision that would extend regulations and requirements to some providers that service Tricare beneficiaries, including new record-keeping and employment requirements.
“At a time when the administration and Congress agree that federal rules and regulations need to be seriously reviewed and revised, the DoL’s decision to expand new contractual requirements to Tricare providers seems misguided and misplaced,” NACDS president and CEO Steve Anderson said.
The NACDS filed the brief over concerns that the judge’s decision could create a precedent whereby Tricare-providing pharmacies could be subject to the regulations, even though pharmacies have no contractual obligations to the federal government, and that the regulations could force the pharmacies out of the Tricare system.
J&J: Extended-release tapentadol may reduce pain associated with diabetes complication
RARITAN, N.J. — A drug made by Johnson & Johnson may be effective in reducing pain in patients with a complication of diabetes, according to a late-stage clinical study.
The phase-3 study, published in the January issue of the journal Current Medical Research and Opinion, found that extended-release tapentadol was more effective than placebo in relieving moderate to severe chronic pain in patients with diabetic peripheral neuropathy. J&J markets an immediate-release formulation of the drug under the brand name Nucynta, which the Food and Drug Administration approved in November 2008.
“What’s encouraging is that at the beginning of this study, the average pain rating across the entire group of patients was severe, but after three weeks on tapentadol ER, the average pain score dropped substantially to a range considered to be mild pain,” therapeutic leader for pain at J&J subsidiary Ortho-McNeil-Janssen Scientific Affairs Bruce Moskovitz said. “After double-blind randomization, the group of patients that stayed on tapentadol ER maintained its pain reduction, while the group that switched to placebo experienced a significant increase in its average pain score.”