Lofexidine is the only non-opiate, non-addictive treatment approved in the United Kingdom used to manage withdrawal symptoms in patients undergoing opiate detoxification
Britannia Pharmaceuticals has signed a licensing agreement with US WorldMeds to further develop and launch Britannia's non-addictive drug addiction treatment Lofexidine Hydrochloride in the United States.
The two companies, who were brought together by Parsons Strategic Associates, have been working together for the past several months to complete the agreement. US WorldMeds intends to negotiate with the National Institute on Drug Abuse (Nida), National Institutes of Health and US Department of Health Services to conduct further studies aimed at bringing Lofexidine to patients in the USA.
US WorldMeds will assume all regulatory and marketing initiatives and the commercialisation of the product.
Lofexidine is the only non-opiate, non-addictive treatment approved in the United Kingdom used to manage withdrawal symptoms in patients undergoing opiate detoxification.
It is effective in reducing the symptoms associated with withdrawal such as chills, vomiting, sweating, stomach cramps, diarrhea, muscle pain, and runny nose and eyes. Lofexidine has been available in the United Kingdom for several years, under the brand name BritLofex.
In the UK, the treatment is responsible for approximately 20,000 detoxifications per year. The drug's proven level of safety allows it to be used in an outpatient context, giving patients another option in parts of the country and world where treatment clinics are not readily available.
"We have seen the tremendous impact that BritLofex has on the lives - and recovery - of addicts in the UK for more than a decade and have been working to bring this treatment to the USA for some time," said Max Noble, managing director of Britannia.
"We have been searching for a competent and motivated US partner to take this important drug through FDA approval and are thrilled to have found exceptionally talented, knowledgeable and passionate industry experts at US WorldMeds.
"We have tremendous confidence in US WorldMeds' commitment and ability to bring Lofexidine to the US patients who need it." In 1996, Britannia began working with Nida to bring the treatment to market in the USA.
As part of this work, in April 2002, a Phase III trial investigating the use of Lofexidine for the treatment of opiate withdrawal symptoms was halted due to significant evidence of efficacy in the Lofexidine treatment group as compared with a placebo group.
The Data and Safety Monitoring Board (DSMB) for the trial determined that due to the overwhelming efficacy demonstrated by Lofexidine, it would be unethical, to those receiving the placebo, to continue the clinical trial.
"Lofexidine has the potential to fundamentally change the way opiate addiction is treated in the United States and we are thrilled to help turn this potential into reality," said Paul Breckinridge Jones, CEO of US WorldMeds.
"Britannia's non-narcotic, non-addictive formulation is targeted at managing the symptoms experienced by patients undergoing medically supervised opiate withdrawal. "The implications of this treatment are powerful." In addition to the studies that have tested Lofexidine's efficacy in preventing withdrawal symptoms, a pilot study conducted at Yale University tested the drug's efficacy in relapse prevention.
The results of the study, which were presented at the College on Problems of Drug Dependence's annual conference in June 2003, showed that opiate addicts treated with a combination of Lofexidine and an opiate antagonist were more likely to remain opiate-free and suffer no significant adverse effects.
Although the drug does not have a license for relapse prevention as yet, further studies are planned to examine increasing the scope of Lofexidine use to include use as a long-term 'aid to abstinence'.
