Regulators have told Allergan Inc. how to structure a clinical trial for its tazarotene pill to treat psoriasis, the company said Wednesday.
The Irvine drug maker said that it could fund a pivotal clinical trial requested by the Food and Drug Administration and complete the study in “a reasonable amount of time.”
Getting the guidelines for the trial is good for the company,last September the FDA said it couldn’t approve the pill based on data submitted by Allergan.
A trial could prove that the drug’s benefits outweigh its risks.
“We remain committed to providing oral tazarotene to psoriasis patients,”said Scott Whitcup, Allergan’s executive vice president of research and development, in a release.
The pill is a form of the drug maker’s tazarotene cream and gel treatments.
Allergan said during the period that regulators wanted it to conduct a new clinical trial to prove that oral tazarotene isn’t inferior to current treatments for psoriasis.
Allergan’s stock was up less than 1% in trading Wednesday to $77.5 a share.
