Aequus Receives Encouragement from FDA for AQS1301 Development Path

Aequus Pharmaceuticals (TSXV:AQS; OTCQB:AQSZF) announced it received positive feedback from the FDA to target the abbreviated 505(b)(2) clinical pathway for their AQS1301 candidate.
As quoted in the press release:

Upon review of the Company’s pre-Investigational New Drug Application (Pre-IND) submission, the FDA agreed that AQS1301 is a suitable candidate for the 505(b)(2) regulatory pathway for approval in the United States. The FDA advised that a relative bioavailability (BA) study in patients comparing steady state pharmacokinetic (PK) between AQS1301 and the oral form would be acceptable if bioequivalence is established. This would provide a bridge to the aripiprazole safety and efficacy data from the approved Abilify^® label at the target therapeutic doses. The FDA outlined additional standard studies required of a transdermal reservoir patch to evaluate the local safety and to ensure that consistent and predictable dosing is maintained over the seven day dosing period without leakage or damage while being worn. Aequus’ development and manufacturing partner, Corium International, Inc. (NASDAQ: CORI), has extensive experience in the area of developing and manufacturing commercial stage transdermal patches meeting these FDA requirements.
“We are encouraged by the feedback from the FDA on the acceptability of an abbreviated clinical path forward for AQS1301,” said Anne Stevens, Chief Operating Officer and Director of Aequus. “This provides validation for our organization to accelerate partnership discussions for this program as we look to collaboratively advance AQS1301 through clinical studies.”

Click here to read the full press release.

Source: www.marketwired.com