Aequus Pharmaceuticals Inc. expands the market opportunity for its reformulated anti-nausea transdermal patch, AQS1303, into the European market. Diclectin, the oral reference product for AQS1303 for the treatment of nausea and vomiting of pregnancy, has recently received marketing authorization in the United Kingdom under the brand name Xonvea.
Aequus plans to launch AQS1303 in countries where an original oral form has been approved and an accelerated path to approval may exist for reformulated products. The company’s former focus had been on the United States and Canada, where Diclegis/Diclectin has been approved since 2013 and 1983. In those two markets alone, an estimated annual US$200M market opportunity currently exists.
“The potential for our long-acting anti-nausea transdermal patch to enter the European market following a UK approval of Diclectin is a very exciting development for this product,” says Anne Stevens, COO and director of Aequus. “With over five million pregnancies in European countries every year, this is a significant market for us and we are delighted at the possibility of offering this easy to use alternative for women suffering from nausea and vomiting during their pregnancy.”
Following a review by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) in June 2018, Xonvea is expected to be available in the UK later this year, followed by further filings for approval in additional European territories. These approvals could provide the basis for a regulatory approval via a hybrid (accelerated) route for Aequus’ anti-nausea patch in the European market.