Aequus Receives Positive FDA Regulatory Guidance for Anti-Nausea Patch
FDA has confirmed that an abbreviated 505(b)(2) regulatory pathway would be appropriate for the submission of AQS1303, Aequus’ long-acting anti-nausea patch for nausea and vomiting associated with pregnancy, for approval in the United States;
FDA has indicated that a bioequivalence study to bridge oral Diclegis® safety and efficacy data with AQS1303 is likely acceptable, reducing the clinical requirements for the program compared to a typical new chemical entity drug submission;
FDA has agreed with Aequus’ proposed clinical plan for AQS1303 which is expected to include only a single clinical efficacy study;
This long-acting anti-nausea transdermal patch is intended to solve for the heavy pill burden of the current oral version which is currently dosed up to 4 times per day in women with nausea and vomiting of pregnancy;
The oral version of this medication sold approximately $186M USD in the United States in 2017, according to IQVIA data.
VANCOUVER, British Columbia, May 03, 2018 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (AQS.V) (AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that the Company has received positive feedback from the US Food and Drug Administration (“FDA”) on its pre-Investigational New Drug (“pre-IND”) submission for the Company’s long-acting anti-nausea transdermal patch, AQS1303. Through the pre-IND feedback, the Company has received clear regulatory guidance for AQS1303. The FDA confirmed that the planned Section 505(b)(2) abbreviated regulatory pathway, which allows for the Company to reference safety and efficacy data of the original oral tablet Diclegis®, is appropriate for submission in a New Drug Application (“NDA”) for the program in the United States.
“We are very encouraged with the responses from the FDA on our anti-nausea program,” said Doug Janzen, Chairman and CEO of Aequus. “The pre-IND feedback met our expectations, confirming our planned clinical program and providing a clear regulatory path forward. The feedback signals positive support for this program and further confirms our overall strategy of improving patient outcomes through alternative delivery methods. We look forward to using this guidance in conjunction with our current development and clinical progress to optimize AQS1303 for success.”
“Camargo’s goal is to guide our clients in the most cost- and time-effective manner through the 505(b)(2) regulatory pathway, while driving commercial success for our client-partners,” said Ken Phelps, President and Co-Founder of Camargo Pharmaceutical Services. “We look forward to continuing work with Aequus to advance their anti-nausea patch for pregnancy nausea and vomiting, to benefit patients worldwide.”
In support of the Company’s planned clinical strategy, the FDA indicated that a pharmacokinetic bridging strategy, to allow bridging to the safety and clinical pharmacology information from Diclegis®, and a single clinical efficacy study, would likely be acceptable for an NDA submission. The FDA also outlined additional standard studies required of a transdermal patch to evaluate the local safety and to ensure that consistent and predictable dosing is achieved over the dosing period.
Aequus owns global rights to this program and is excited about advancing both clinical and strategic discussions as the Company advances AQS1303 towards commercialization in major markets.
Aequus’ long-acting transdermal anti-nausea patch, AQS1303, contains the combination of pyridoxine and doxylamine (the active ingredients in Diclegis®/Diclectin®) currently used to treat nausea and vomiting of pregnancy. AQS1303 is designed to provide patients with a convenient and reliable delivery system as an alternative to the currently marketed oral form, which is dosed up to four times per day. According to IQVIA data, Diclegis® sales in the United States were approximately $186M USD for 2017.
Aequus has advanced AQS1303 through an initial Proof of Concept clinical study, completed in September 2017. The Proof of Concept study was a single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis®/Diclectin®, and was successfully completed in nine healthy female volunteers. The results suggested that sustained delivery of therapeutic levels of the active ingredients through the skin over a multi-day period is possible with the current formulation. The formulation was well tolerated with no serious adverse events reported.
Based on FDA feedback, this product is expected to follow a Section 505(b)(2) New Drug Application, an abbreviated clinical pathway in which the FDA would allow for the Company to reference safety and efficacy data of the original oral tablet form of the medication.