CHINESE FIRM TO DEVELOP CEPHALON'S FENTANYL DRUG
Beijing Med-Pharm, a drug marketing and distribution company, announced it has entered into a master services agreement with Cephalon under which Beijing Med-Pharm will complete the clinical development and registration process for certain Cephalon products in China.
The initial focus of the agreement will be Fentora (fentanyl buccal tablet), which received FDA approval in September, for the management of breakthrough pain in patients with cancer who are already receiving and are tolerant to opioid therapy. The Chinese State Food and Drug Administration (SFDA) usually accepts registration of pharmaceuticals previously approved in the United States on the basis of a single clinical trial conducted in China, according to the company. Beijing Med-Pharm will design and conduct a Chinese registration trial for Fentora, with the application process beginning in 2007.
"We intend for our collaboration on Fentora to be the first in a successful partnership with Beijing Med-Pharm that will facilitate the incorporation of Cephalon products into medical care in China," Robert Roche, executive vice president of worldwide pharmaceutical operations at Cephalon, said.
Fentora is the first tablet formulation of the opioid fentanyl and the first new medication approved for the management of breakthrough pain in opioid-tolerant cancer patients since 1998. The tablet is placed between the upper cheek and gum above a rear molar tooth. With Cephalon's OraVescent drug-delivery technology, approximately half of the dose is absorbed directly across the lining of the upper cheek and into the bloodstream more quickly than if it were swallowed.
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