ACADIA: FDA Grants Breakthrough Therapy Status To NUPLAZID

(RTTNews) - ACADIA Pharmaceuticals Inc. (ACAD), a biopharmaceutical company, Tuesday said the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to NUPLAZID (pimavanserin) for the treatment of Parkinson's disease psychosis.

ACAD, which closed at $23.98 on Friday, climbed 14.7 percent in pre-market activity.

NUPLAZID is a selective serotonin inverse agonist which, if approved, will establish a new and distinctly different pharmacological approach to treating psychosis.

It has successfully completed a pivotal Phase III trial in Parkinson's disease psychosis, which the FDA has agreed can serve as the basis, together with supportive data from other studies, for a New Drug Application.

ACADIA plans to submit the NUPLAZID NDA to the FDA near the end of this year.

The Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs that are meant to treat serious or life-threatening conditions.

For indications without an approved therapy, drugs qualifying for this designation must show a substantial and clinically meaningful effect on an important outcome when compared with placebo.

The Breakthrough Therapy designation is distinct from priority review, which can also be granted to the same drug if the relevant criteria are met.