FDA OKs new indication for Janssen's Nucynta and fast tracks Zytiga sNDA

There were two pieces of good news for US health care giant Johnson & Johnson (NYSE: JNJ) subsidiaries yesterday. First, the US Food and Drug Administration has approved Janssen Pharmaceuticals’ supplemental New Drug Application (sNDA) for Nucynta ER (tapentadol) extended-release tablets, an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Nucynta ER is the first and only opioid approved by the FDA for neuropathic pain associated with DPN. In addition to this new indication, Nucynta  ER is currently approved 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.

Diabetes affects nearly 26 million people in the USA, and around 60% to 70% of people with diabetes have some form of neuropathy. The most common type of neuropathy is DPN, which causes pain or loss of feeling in the toes, feet, legs, hands and arms; it may also include a persistent burning, tingling or prickling sensation. It is estimated that DPN affects nearly eight million people in the USA. Because the complex pathophysiology of DPN involves both central and peripheral mechanisms, certain patients with DPN may require treatment with multiple agents.