Johnson & Johnson R&D seeks FDA approval for Nucynta supplemental

On August 25, 2011 Johnson & Johnson Pharmaceutical Research and Development, L.L.C (J&JPRD) received approval from the US Food and Drug Administration for the drug NUCYNTA ER to manage the symptoms associated with diabetic peripheral neuropathy (DPN) in adults.

 

A little less than two months later, (October 31, 2001) the company has submitted a new request to approve a supplemental drug for NUCYNTA ER.

Diabetic peripheral neuropathy is a disorder that affects the nerves in the body, and can affect anywhere from 60 to 70 percent of people with diabetes. Because the nerves are everywhere in the body, the never disorder can affect any organ that falls prey to nerve damage.

 

Some common symptoms include numbness and loss of feeling in the hands and feet; severe pain is associated in the most chronic cases.

 

DPN is usually associated with humans who have had diabetes for longer than 25 years, those with type two diabetes, those who have difficulty managing blood glucose levels, or a combination of the above Some patients currently receiving treatment are still experience a substantial amount of pain.

The supplemental drug is intended for the management of pain, whether moderate or severe, and provides an all day continuous relief from a tablet taken orally. Testing consisted of phase three double-blind, randomized, active-and placebo-controlled studies in order to determine the safety of the drug, and the effectiveness of the drug.

 

According to the testing, NUCYNTA ER was shown to provide relief of pain from DPN in a safe and effective manner when compared to the effects of the placebo.