Aequus Pharmaceuticals (CVE:AQS) said today that it won approval from Health Canada to launch a proof-of-concept trial to evaluate the bioavailability and safety of the company’s long-acting transdermal anti-nausea patch.
The device is made up of a combination of pyridoxine and doxylamine. The traditional form is delivered orally up to 4 times per day.
The proof-of-concept study is a trial comparing Aequus’ patch to the currently approved oral version, Diclegis/Diclectin, in 9 healthy volunteers. Data from the trial is slated to be published by the end of this quarter, according to the Vancouver-based company.
“Diclegis/Diclectin has provided symptomatic relief to millions of women to date, but in its current form it is dosed orally multiple times per day which can induce gag reflexes in women experiencing nausea during pregnancy,” director & chief operating officer Anne Stevens said in prepared remarks. “We are very excited about the potential for this program and believe a long-acting patch could provide a much needed solution for this medication, giving patients a more comfortable and convenient dosing alternative.”
Aequus also said it is preparing for a pre-investigational new drug meeting with the FDA to outline the clinical strategy for approval in the U.S. The company plans to pursue a 505(b)(2) new drug application, using safety and efficacy data from the oral tablet form of the medication.
The company also said it is on the lookout for a strategic partner with which to strike a commercialization deal.