In the wake of a disastrous French clinical trial that left one volunteer dead, Johnson & Johnson ($JNJ) has voluntarily suspended development of a similar drug until more information comes to light.
The drug, JNJ-42165279, is an inhibitor of the enzyme FAAH, much like the treatment from Bial that led to 6 hospitalizations and one death in a Phase I study last week. Short for fatty acid amide hydrolase, FAAH helps regulate the body's cannabinoid receptors, making it a seemingly promising target for the treatment of pain and anxiety. But the tragic turn of the Bial study, in which volunteers developed serious neurological conditions, has spurred new questions about the safety of FAAH inhibition.
Now J&J is pausing Phase II development of its similar therapy, suspending a pair of studies testing JNJ-42165279 in major depressive disorder and social anxiety. The plan is to keep the program on hold until investigators have more information, J&J said. The company noted that it hasn't seen any reports of serious side effects tied to JNJ-42165279 in either study, nor in prior Phase I trials on the drug.
FAAH is not a novel target for drug developers. Pfizer ($PFE) moved into Phase II with the FAAH-blocking PF-04457845 in 2012 but nixed the program after its drug failed to significantly relieve pain due to osteoarthritis of the knee. Despite the miss on efficacy, the drug was "well tolerated," investigators said at the time.
Last year, Pfizer terminated a study comparing PF-04457845 against placebo in patients with post-traumatic stress disorder, saying the move was based on "portfolio prioritization" and not issues related to safety or efficacy.
And Sanofi has abandoned a pair of FAAH programs involving the drug SSR411298, terminating a Phase II trial in cancer pain in 2010 for "strategic reasons" and then discontinuing development in depression after completing a second Phase II study in 2012.
Similarly, Vernalis discontinued development of an FAAH inhibitor for neuropathic pain last year after the drug missed its primary endpoint in Phase II.
Meanwhile, French authorities are investigating what went wrong in the Bial trial, which administered the drug in question to 90 healthy volunteers. The 6 hospitalized patients came near the end of the dose-escalating study, receiving multiple daily administrations of the drug, the company said. French health minister Marisol Touraine said in a news conference on Friday that investigators had yet to determine whether the problems were related to the drug's mechanism of action or the result of contaminated doses, but investigators are calling back all of the trial participants to screen them for signs of neurological impairment.
- read J&J's statement