FDA Requests Info for New Chronic Pain Drug Formulation

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. received a Complete Response letter from the FDA regarding its New Drug Application (NDA) for tapentadol-extended release tablets.

Johnson & Johnson filed the application for the drug in late 2009 to market the drug as an oral analgesic for the moderate to severe chronic pain, for patients 18 or older.

The FDA did not request any new clinical studies to evaluate the efficacy or safety of the product. The agency did request data regarding the conversion of the extended release formulation used in the clinical efficacy and safety trials to a different extended release formulation that is designed to increase mechanical resistance to breaking or crushing.

“We will engage FDA in active discussions as quickly as possible so that we can address the requests in the Complete Response letter,” said Juergen Haeussler, MD, Therapeutic Area Head, Analgesia, J&JPRD, in a press release. “We remain fully committed to bringing tapentadol ER to patients experiencing chronic pain as quickly as possible.”

An estimated 100 million Americans suffer from chronic pain, according to the National Institutes of Health. Among the most common chronic pain conditions are osteoarthritis and low back pain. Osteoarthritis affects 16 million Americans and low back pain affecting four out of five million Americans.

Tapentadol is a centrally acting oral analgesic that binds to mu-opioid receptors and inhibits norepinephrine reuptake. While the exact mechanism of action is not known, the drug affect established pain pathways, which is thought to be responsible for pain relief. The tapentadol molecule is classified as Schedule II of the Controlled Substances Act.

Nucynta (tapentadol) CII Immediate Release Formulation was approved by the FDA on November 20, 2008, and is available by prescription only for the relief of moderate to severe acute pain in patients, 18 years or older. PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., markets Nucynta in the country. To date, more than 450,000 total prescriptions for the drug have been written since the launch of the medication in June 2009.

Johnson & Johnson seeks to bring new and innovative products to patients and physicians for the treatment and management of pain. J&J Pharmaceutical Research & Development, L.L.C. is leveraging drug discovery and drug development in a variety of therapeutic areas, including CNS, Internal Medicine and Oncology, to address unmet medical needs worldwide.

PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is a major health care company in the United States that states it is dedicated to the needs of primary care providers who serve a vital role on the frontline of medicine.