Aequus Pharmaceuticals Inc., a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that it has received positive feedback from the US Food and Drug Administration (FDA) to pursue the abbreviated 505(b)(2) clinical pathway for the company’s once-weekly transdermal aripiprazole patch, AQS1301, in development for the treatment of certain psychotic disorders.
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 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.
The outcome of the interaction with the FDA provides clarity on the requirements for Aequus and the development goals for AQS1301 in order to achieve FDA approval under 505(b)(2), said Gary Barnette, Senior Vice President of Scientific and Regulatory Affairs, Camargo Pharmaceutical Services, LLC. We are pleased to be partnered with Aequus and to assist in achieving this important milestone.
Aequus owns the global rights to this program, and will look to find a strategic partner to advance AQS1301 through the planned clinical studies and towards commercialization in major markets.
A Section 505(b)(2) NDA is a new drug application in which the FDA and applicant may rely on certain investigations of safety and effectiveness that were previously conducted by someone other than the applicant, and is often applicable to an active drug substance that has previously been approved in a different dosage form.
