J&J Pharmaceutical R&D submits application to FDA for analgesic
J&J Pharmaceutical Research & Development, L.L.C. announced that it has submitted a supplemental New Drug Application to the U.S. FDA for NUCYNTA® ER (tapentadol) extended-release tablets.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for NUCYNTA® ER (tapentadol) extended-release tablets, an oral analgesic, for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults. The FDA approved NUCYNTA® ER on August 25, 2011, 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.
In the United States, there are nearly 26 million people living with diabetes and, over time, they can develop a type of nerve damage called neuropathy. Approximately 60 to 70 percent of people with diabetes have some form of neuropathy. The most common type is DPN, which causes pain or loss of feeling in the toes, feet, legs, hands, and arms. It is estimated that painful DPN affects 10 to 20 percent of all patients with diabetes, and many patients on current treatments still experience considerable pain.
The submission is based on a full clinical development program, including Phase 3 double-blind, randomized, active-and placebo-controlled studies. These clinical trials explored the efficacy and safety of NUCYNTA® ER for the management of neuropathic pain associated with DPN in adults.
Data from these studies provide evidence that NUCYNTA® ER has efficacy to reduce diabetic peripheral neuropathic pain compared to placebo. The data also provide evidence of long-term safety and tolerability of NUCYNTA® ER.
J&JPRD is conducting the clinical program for NUCYNTA® ER in the United States. J&JPRD submitted the sNDA on behalf of Janssen Pharmaceuticals, Inc., an affiliated company that holds the NDA for NUCYNTA® ER. Janssen Pharmaceuticals, Inc., markets NUCYNTA® ER in the United States.
This filing represents the ongoing commitment of J&JPRD and Janssen to bring new and innovative products to patients and physicians for the treatment and management of pain.
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 J&JPRD 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 is 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; Grunenthal GmbH discovered tapentadol and markets immediate- and extended-release formulations of tapentadol (PALEXIA®) in various countries in Europe.
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