FDA approves Janssen Pharmaceuticals analgesic

Janssen Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved NUCYNTA® ER, an oral analgesic taken twice daily, for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

 

Although the exact prevalence is unknown, information from the Centers for Disease Control and Prevention and the American Pain Foundation suggests that more than 42 million Americans age 20 and over suffer from chronic pain. Chronic pain is the most common cause of long-term disability, and almost one-third of all Americans will experience severe chronic pain at some point in their lives. Yet despite the treatments available, additional treatment options still are needed to help patients manage their pain appropriately and effectively, according to research published by the American Pain Society.

 

“In clinical trials, NUCYNTA® ER demonstrated proven efficacy for treating moderate to severe chronic pain,” said Paul Chang, M.D., Vice President, Medical Affairs, Internal Medicine, Janssen Pharmaceuticals, Inc. “We are pleased with the FDA’s decision to approve NUCYNTA® ER as it represents an important new option to help people with chronic pain.”

 

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Grünenthal GmbH, a privately-owned pharmaceutical company based in Aachen, Germany, conducted the double-blind, randomized, active- and/or placebo-controlled phase 3 studies that evaluated the efficacy and safety of NUCYNTA® ER for the treatment of moderate to severe chronic low back pain and painful diabetic peripheral neuropathy. Additionally, safety also was evaluated in more than 1,100 patients with moderate to severe chronic pain over a one-year period. The findings demonstrate efficacy and safety, a favorable tolerability profile and favorable discontinuation rates.

 

“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,” said Sunil J. Panchal, M.D., President, National Institute of Pain.* “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.”

 

To support the appropriate and effective management of chronic pain, Janssen Pharmaceuticals, Inc. believes it is also essential to support educational programs about the safe and responsible use of pain medicines and the prevention of inappropriate use.

 

To help ensure the risks of NUCYNTA® ER are communicated accurately, Janssen Pharmaceuticals, Inc. has developed a Risk Evaluation and Mitigation Strategy (REMS) for the medication, in collaboration with the FDA. This REMS, which is similar to those developed for other medicines in this category, educates prescribers about the potential for abuse, misuse, overdose and addiction from exposure to NUCYNTA® ER. To supplement the REMS, the company also utilizes surveillance methodologies to monitor for inappropriate use of its products.

 

About Tapentadol, NUCYNTA® ER and NUCYNTA®

 

Tapentadol is a centrally-acting synthetic analgesic. The tapentadol molecule is classified as Schedule II of the Controlled Substances Act.

 

NUCYNTA® ER (tapentadol extended-release tablets) represents the ongoing commitment of Janssen Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. to bring new and innovative products to patients and physicians for the treatment and management of pain.

 

NUCYNTA® ER is an oral analgesic indicated for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. It is taken twice daily and available in 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths.

 

NUCYNTA® (tapentadol immediate-release tablets) was approved by the FDA on November 20, 2008, for the relief of moderate to severe acute pain in patients 18 years of age or older. It is available in 50 mg, 75 mg, and 100 mg strengths.

 

Both NUCYNTA® and NUCYNTA® ER are available by prescription only.

 

Outside the United States, tapentadol is marketed by Janssen Inc. in Canada; Grünenthal GmbH discovered tapentadol and markets immediate- and extended-release formulations of tapentadol (PALEXIA®) in various countries in Europe.

 

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Janssen Pharmaceutical KK, Japan, are developing tapentadol in Japan. In addition, Janssen Pharmaceutical companies have rights to develop and market immediate- and extended- release formulations of tapentadol in select European countries and certain countries in Latin America, the Asia-Pacific region, Africa and the Middle East.