FDA OKs Cephalon's Fentora

The drug treats pain in cancer patients.
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Cephalon

(CEPH)

said late Monday that it received government approval to begin marketing a cancer-pain drug, Fentora.

The company announced that the Food and Drug Administration had endorsed the drug for patients who are receiving -- and who can tolerate -- opioid therapy. Fentora's label carries the agency's strongest warning about the dangers of abusing the drug, which is classified in the same category as powerful drugs like morphine and methadone.

Fentora is approved for breakthrough pain, or sharp spikes in pain that the company says can last from three minutes to 60 minutes.

Cepahlon had received

conditional approval from the FDA in late June. At the time, the company said it had expected full approval in three to six months. The company didn't identify the reasons for the agency's delay.

Cephalon said it expects Fentora to be available in the U.S. during the first week of October. Fentora, a tablet that dissolves in the mouth, is a successor to Actiq, a cancer-pain treatment in the form of a lollipop.

Earlier this year, Cepahlon signed a truce with

Barr Laboratories

(BRL)

, settling a patent dispute and allowing Barr to begin

marketing a generic version of Actiq in December.

Fentora contains the powerful painkiller fentanyl, which is the key ingredient in Actiq and which is also sold by other companies as an injectable treatment and as a drug delivered via a skin patch.

Cephalon is studying Fentora as a treatment for other types of pain, including back pain. The company says Fentora's pain-relieving power can affect the body much faster than pills or tablets that are swallowed, and can require 30 to 45 minutes to take effect as they are absorbed in the gastrointestinal tract. Cephalon says approximately half of Fentora is absorbed directly across the lining of the upper cheek, entering the bloodstream faster.