Johnson & Johnson's ($JNJ) stellar year for drug approvals continues. U.S. regulators have given a market nod to J&J unit Janssen's extended-release version of pain pill Nucynta. The company can now market the drug for moderate to severe chronic pain in adults who need continuous treatment with an opioid analgesic.
The approval follows J&J's study showing the safety and efficacy of the drug in Phase III studies involving patients with chronic low back pain and serious aches from diabetic peripheral neuropathy. The drug also proved safe in more than 1,100 patients with chronic pain. Due to potential for abuse and other risks in associated with the drug, according to J&J, the approval comes with a risk evaluation and mitigation strategy (REMS) tag.
J&J can add this win at the FDA to what is turning out to be a banner year for new drug approvals for the healthcare giant. In April, U.S. regulators approved the company's prostate cancer drug Zytiga. Also, the company and partner Vertex ($VRTX) have garnered marketing approval for the hepatitis C drug Incivek in both the U.S. and Europe. Nucynta was initially approved in 2008, but the extended-release version offers the convenience of taking the drug twice a day.
And chronic pain is a big problem in the U.S. More than 42 million Americans over the age of 20 suffer from chronic pain, which is also a leading cause of disability.
"Chronic pain is difficult to manage, and even with the treatments available today, it can be a challenge to balance pain relief with a patient's ability to tolerate the medicine," Dr. Sunil Panchal, president of the National Institute of Pain, said in J&J's release. "People with chronic pain will continue to need additional options, so an approval like this is welcome news for this community and the people who suffer from this often debilitating condition."
- here's the Janssen release
- check out Reuters' report