Follow Forum_Psych on Twitter

Display results as :

Rechercher Advanced Search

We have 222 registered users
The newest registered user is raheelmemon

Our users have posted a total of 1140 messages in 613 subjects
If you are seeing this, you have attempted to link to the UpToDate widget but are experiencing a problem. Please visit UpToDate for more information.

FDA has Approved Tapentadol (Nucynta): an Extended-Release Oral Opioid

Go down

FDA has Approved Tapentadol (Nucynta): an Extended-Release Oral Opioid

Post  Admin on Sat Aug 27, 2011 5:46 pm

FDA has approved Tapentadol (Nucynta), an extended-release oral opioid, to treat severe chronic pain

Aug 26, 2011.
Nucynta ER (tapentadol extended release) has been approved by the U.S. Food and Drug Administration to treat moderate-to-severe chronic pain in adults, maker Janssen Pharmaceuticals said. The original formulation of Nucynta was approved by the FDA in 2008.

The approval is based on a randomized, double-blind, controlled phase III study that tested tapentadol as a treatment for moderate to severe low-back pain and diabetic peripheral neuropathy.

Tapentadol was also well-tolerated, the company said. Opioids can cause a number of side effects, including constipation, that may cause patients to discontinue their use.
A 2010 phase III study comparing the drug to oxycodone in patients with painful knee osteoarthritis found that tapentadol provided effective pain relief with fewer of the gastrointestinal side effects seen with oxycodone.

The approval also comes with a Risk Evaluation and Mitigation Strategy (REMS), similar those approved for other opioids, meant to educate prescribers about the potential of abuse, misuse, overdose, and addiction with extended-release tapentadol.

The CDC estimates that 42 million Americans over the age of 20 suffer from chronic pain.

Click on to post your comments

Posts : 948
Points : 2102
Reputation : 0
Join date : 2011-02-19
Location : Philadelphia

Back to top Go down

Back to top

- Similar topics

Permissions in this forum:
You cannot reply to topics in this forum