The patch, which combines pyridoxine hydrochloride and doxylamine succinate, is intended to treat nausea and vomiting associated with pregnancy. The oral form of pyridoxine hydrochloride, Diclegis, is dosed up to four times a day.
The single-dose comparative bioavailability study enrolled nine healthy female volunteers, the company reported. The trial showed that the patch can deliver therapeutic levels of both medicines through the skin over a multi-day period and that it did so without any serious adverse events.
“We are greatly encouraged by the results of this initial Proof of Concept clinical study and believe the study clearly demonstrated the feasibility of a fixed dose combination patch containing doxylamine and pyridoxine for the treatment of nausea and vomiting of pregnancy,” chief scientific officer Donald McAfee said in prepared remarks.
“We are very excited about the potential for this product and these initial results bring us one step closer to providing an elegant solution for pregnant women suffering from nausea and vomiting,” chairman & CEO Doug Janzen added. “We look forward to the continued advancement of this program and will be engaging with both potential partners and the FDA over the coming months.”
Aequus said it will use the study’s data to support a pre-investigational new drug submission with the FDA. The product is slated to follow a 505(b)2 new drug application pathway, the company said, which would allow Aequus to reference safety and efficacy data from the original oral tablet form of the drug.
Although Aequus retains the global rights to the program, it is on the hunt for a strategic partner to commercialize the patch in major markets.