FDA suspends clinical trial of lonidamine for BPH
FDA has suspended a Phase 3 trial of Threshold Pharmaceuticals' lonidamine for treating benign prostatic hypertrophy (BPH) after six participants showed liver problems. The agency said three men experienced adverse events in the European/Canadian Phase 3 trial, and three other men in trials developed elevated liver enzymes.
Lonidamine, also known as TH-070, was first approved to treat cancer in three European countries in the mid-1980s. The company said FDA requested additional information on the drug's acceptable dose and duration of treatment in BPH patients. Threshold said it would stop administering the drug to 567 patients enrolled in a Phase 3 European and Candian trial. It will continue two other trials, and will cancel a third planned for this year.
Paxil linked to increased suicidality risk in young adults
FDA and GlaxoSmithKline warned health care professionals about a potential increased risk of suicide associated with use of Paxil (paroxetine HCl) tablets or oral solution or paroxetine exten-ded-release tablets (Paxil CR). Careful monitoring of all patients regardless of the condition being treated is needed, they said. Such monitoring may be of particular importance in young adults and those whose depression is improving, FDA said in a MedWatch alert based on data from a recent meta-analysis of suicidal behavior and ideation in placebo-controlled clinical trials of paroxetine in adults with psychiatric disorders such as major depressive disorder and other depression and non-depression disorders. The trials included 8,958 paroxetine-treated patients and 5,953 patients who received placebo.
FDA said study results showed that paroxetine therapy compared with placebo was linked to an increased frequency of suicidal behavior in young adults 18-24 years old. Although not statistically significant, the increase occurred in patients with depressive and nondepressive conditions alike. No such increase was seen in those ages 25 and older.
FDA said the potential increased risk for suicidal behavior in major depressive disorder patients was observed despite substantial evidence for efficacy in those receiving paroxetine, as determined using standardized disease-specific instruments. Most patients had an identified social stressor at the time of the event.
FDA has suspended a Phase 3 trial of Threshold Pharmaceuticals' lonidamine for treating benign prostatic hypertrophy (BPH) after six participants showed liver problems. The agency said three men experienced adverse events in the European/Canadian Phase 3 trial, and three other men in trials developed elevated liver enzymes.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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