Lofexidine Hydrochloride — for treatment of opiate withdrawal symptoms.

We’re looking forward to a US release of Lofexidine. On October 9, 2006, US WorldMeds announced that it is currently enrolling 264 study subjects across 14 clinical trial sites nationwide in USWM-001, a major, pivotal Phase 3 clinical trial of Lofexidine. When approved by the FDA, Lofexidine will be the first and only non-narcotic drug approved to relieve the debilitating withdrawal symptoms associated with opiate detoxification.

The National Institutes of Health (NIH) estimates that drug and alcohol addiction, which affects millions of people in the United States, costs the nation nearly $500 billion a year - more than diabetes and cancer combined. The number of hardcore heroin abusers in the United States is estimated between 600,000 and 1 million. In addition, the United States Substance Abuse and Mental Health Services Administration recently reported that 2.4 million US citizens began using opiates for non-medicinal purposes over the past 12 months.

Currently, the only FDA approved option for treating opiate addiction is through the use of methadone and buprenorphine, both of which are synthetic opiates with their own addictive tendencies. Both drugs are also scheduled drugs requiring individuals seeking treatment to visit only a limited number of currently available licensed detox centers and/or licensed practitioners. Many opiate addicts lack access to such care. When approved by the FDA, Lofexidine would be the first and only non-narcotic drug for the relief of the debiltating withdrawal symptoms associated with opiate detoxification.

Lofexidine is marketed as BritLofex in the United Kingdom where the drug has been used in the successful detoxification of over 200,000 opiate addicts.

US WorldMeds has established a goal of submitting a New Drug Application (NDA) with the FDA in 2008 to secure approval for the commercial launch of Lofexidine.

Please refer to our "Newsroom" and "Contact Us" pages for more information on Dantrolene or Lofexidine or to contact a representative of US WorldMeds.