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Aequus Pharmaceuticals filed a Clinical Trial Application with Health Canada for their upcoming clinical study for transdermal anti-nausea patch, AQS1303.
Aequus Pharmaceuticals (TSXV:AQS; OTCQB:AQSZF) filed a Clinical Trial Application with Health Canada for their upcoming clinical study for transdermal anti-nausea patch, AQS1303.
As quoted in the press release:
Upon approval of the CTA, which is expected in early July, the Company plans to initiate a single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis®/Diclectin®, in nine healthy volunteers.
“We are very excited to see the continued advancement of this program,” said Anne Stevens, Chief Commercial Officer at Aequus. “A long-acting patch that reliably delivers a sustained dose of pyridoxine and doxylamine will benefit patients by reducing both the pill burden and maintaining a steady state of therapeutic delivery, while treating symptoms of nausea and vomiting.”
AQS1303 is a long-acting transdermal patch intended for the treatment of nausea and vomiting of pregnancy (“NVP”). AQS1303 would provide patients with a more convenient and reliable delivery system as an alternative to the currently marketed oral form, which is dosed up to four times per day. Currently, the oral form of Diclegis® is the only FDA approved medication for morning sickness in pregnant women and in 2015 reached sales in the United States of approximately U.S.$120 million. A long-acting transdermal form of pyridoxine/doxylamine is being developed by Aequus to address the risk of missed doses due to emesis (vomiting) and to provide consistent and sustained symptomatic relief.
Click here to read the full press release.
Source: www.marketwired.com
