Drug maker Cephalon has settled its patent lawsuit with Barr Pharmaceuticals Inc., agreeing to give Barr a license to sell a generic version of Cephalon's potent painkiller Fentora in 2018, according to the Securities and Exchange Commission. Barr will receive a non-exclusive, royalty-free right to sell the drug one year before Cephalon's patent expires. However, if another generic version of Fentora hits the U.S. market before Barr can launch its brand, Barr can introduce its version even earlier than 2018.
Two years ago, the Food and Drug Administration (FDA) considered expanding the approved usage for Cephalon Inc.'s powerful painkiller Fentora to go beyond its limited use in the treatment of opioid-tolerant cancer patients. Originally approved by FDA in 2006, Fentora grew to enjoy a sizeable off-label usage for the treatment of back pain, injuries and headaches, and Cephlon sought to have this off-label use approved by the FDA. But the request was marked by at least five reported deaths from the unapproved use of Fentora.
Pain management can be a serious health issue for cancer patients, separate and apart from their underlying cancer, according to the National Institutes of Health. Finding an effective treatment for these patients can be harrowing. Many are put on opioids, drugs that decrease one's perception of and reaction to pain, as well as increase one's pain tolerance.
Cephalon peddled potent and potentially harmful painkillers as if they were "actual lollipops," according to the U.S. Attorney's office. The statement was released following an investigation into the drug company's marketing activities. Cephalon was also slapped with a $425 million penalty.
The Food and Drug Administration (FDA) has granted approval to drug maker Coviden for a generic version of the painkiller Actiq (fentanyl citrate), made by Cephalon. Coviden plans to start selling six different does of the drug, a powerful painkiller prescribed to cancer patients who have become tolerant to opioids. Barr Pharmaceuticals also makes a generic version of Actiq.
The Tennessee Board of Medical Examiners revoked the license of a family physician with more than 25 years experience for prescribing medication to patients without proper justification. Sidi Yousseff Noor practiced at Holston Medical Group, an urgent care clinic with locations in and around Kingston, Tenn. The order claims Noor prescribed drugs including Actiq, Morphine and Ketamine to approximately 75 patients without proper justification while working at Crescent Medical Center in Morristown.
Biopharmaceutical company Cephalon paid more than $9.1 million in 2009 to health care professionals for speaking fees and consulting services. Cephalon was required to disclose the information, available on the company's Web site, along with paying $425 million in settlement charges, after the Department of Health and Human Services charged that the company illegally marketed three of its drugs, including Actiq, a drug approved by the Food and Drug Administration for very limited use to treat breakthrough pain in cancer patients who have built up a tolerance to opioids.
Drug maker Javelin hopes to meet with the Food and Drug Administration (FDA) to discuss approval of its new painkiller, Ereska. The drug is a non-opioid nasal medication designed to treat moderate to severe pain and provide physicians with an accepted and regulated alternative to off-label use and opioids.



