Anti-nausea agent beginning Phase III trials
OPKO Health Inc has announced it is launching a trio of Phase III clinical trials to evaluate how effective their drug Rolapitant® is in dealing with Chemotherapy-Induced Nausea and Vomiting (CINV).
Rolapitant is a Neurokinin-1 (NK-1) receptor antagonist being developed by OPKO and TESARO for patients receiving chemotherapy regimens that are typically known to induce nausea and vomiting to one degree or another.
The company will be running a pair of randomized, double-blind and placebo-controlled clinical trials evaluating the efficacy of a single 200mg oral dose of rolapitant in patients being given highly emetogenic chemotherapy, or HEC. Enrollment for each trial is expected to be around 530 patients, or over 1,000 in all.
The third trial will evaluate the efficacy of a single 200mg oral dose of rolapitant in patients receiving moderately emetogenic chemotherapy, or MEC. This trial will recruit 2,400 cancer patients.
Results are expected sometime in 2013. Currently, rolapitant is an investigational agent only, and not approved by the FDA or any other known regulatory agencies.
Source: Therapeutics Daily
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