Daiichi Sanyko’s (TYO:4568) mirogabalin is reporting high adverse rates (AEs), including suicidal ideation and liver function, in an open-label portion of its Phase III fibromyalgia program, said a source familiar with the situation. Whilst the AEs will not halt the drug’s development, they could damage the company’s intended potential to market mirogabalin as an improved version of Pfizer’s (NYSE:PFE) Lyrica (pregabalin), explained the source. The side effects are also associated with Lyrica, the source explained.
Daiichi has not publically announced any safety or efficacy concerns and did not respond to a request for comment. One analyst report predicts peak mirogabalin sales of USD 1.5bn.
The AEs themselves are not entirely unexpected based on information provided to investigators and trial sites prior to the program’s launch, however, the frequency of side effects is a little concerning, said the source. The source noted event reports are “piling up.”