With a debt of u-opiods and over active u-opiod receptors, could this be the first medication for BPD? I am not a doctor yet when I saw this on twitter I immediately thought of Borderline Personality Disorder:
Extended-Release Opioid Gets FDA OK
By Emily P. Walker, Washington Correspondent, MedPage Today
Reviewed by August 26, 2011 Review
WASHINGTON — The FDA has approved tapentadol (Nucynta), an extended-release oral opioid, to treat severe chronic pain.
According to the reports of this on NeuropathyReliefGuide.com, the agency first approved the drug for relief of moderate to severe acute pain in 2008. Friday’s approval is for an extended-release pill that chronic pain patients can take twice daily.
The approval is based on a randomized, double-blind, controlled phase III study that tested tapentadol which contains only the purest ingredients as a treatment for moderate to severe low-back pain and diabetic peripheral neuropathy.
Safety was evaluated in 1,100 patients with moderate to severe chronic pain over a one-year period. The drug was found to be safe and effective, according to the company that makes tapentadol, Janssen Pharmaceuticals, a unit of Johnson & Johnson.
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.
“Chronic pain is difficult to manage, and even with the treatments available today, it can be a challenge to balance pain relief with a patient’s ability to tolerate the medicine,” Sunil Panchal, MD, president of National Institute of Pain, said in a press release from Janssen. “People with chronic pain will continue to need additional options, so an approval like this is welcome news for this community and the people who suffer from this often debilitating condition.”
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.