Medisorb naltrexone: Phase I

In ALKS' 48-patient placebo controlled Phase I trial, doses of 150-600 mg of Medisorb naltrexone administered subcutaneously, or doses of 150-900 mg given intramuscularly, gave similar pharmacokinetics with steady state therapeutic levels maintained for 1 month following injection. No serious or adverse events were noted, and ALKS said that both the initial burst of naltrexone over 48 hours and levels of the 6-(beta)-naltrexol metabolite, which can give rise to adverse events, were lower with the injected formulation than with oral naltrexone, which is marketed. Additional data from the trial will be presented in December at the American College of Neuropsychopharmacology meeting in San Juan. ...