Canada : Aequus prepares for proof of Concept clinical study for transdermal anti-nausea Diclegis program.
Doxylamine/pyridoxine is currently marketed as Diclegis (US) / Diclectin (Canada) for the treatment of NVP as an oral tablet, dosed up to four times per day and is the only FDA-approved medication to treat this condition. Diclegis has demonstrated strong year over year growth since its US launch in 2013, with sales revenues in 2015 exceeding USD$120M. Aequus has engaged with over 400 women who have suffered from nausea and vomiting during their pregnancy to understand the need for an alternate delivery form of doxylamine/pyridoxine, such as an easy to administer transdermal patch. The results from these discussions highlighted the discomfort women experience while taking oral medications to treat their nausea and vomiting symptoms during pregnancy. The majority of women surveyed by Aequus who had been treated medically for either moderate or severe symptoms experienced gag reflex, immediate vomiting following dosing and/or dry-mouth while trying to take their oral medication and expressed a high level of interest in a convenient, transdermal route of delivery.
Women with severe symptoms who experience vomiting after dosing of their oral therapy are often uncertain as to whether the medication has been absorbed and if taking another dose would be permissible. Transdermal administration of this medication would provide steady-state delivery of the medication, and is expected to provide consistent symptom relief, said Anne Stevens, COO and Director of Aequus. We are delighted to be advancing this program to provide patients with a more comfortable and reliable treatment alternative. This is Aequus second program to be advanced into a clinical Proof of Concept study, and adds significant value to the development arm of our business, said Doug Janzen, President and CEO of Aequus. As we grow into a more mature specialty pharmaceutical company, we remain focused on developing, advancing and promoting products that provide a true benefit to patients.
The primary objectives for the Proof of Concept study will be to assess the bioavailability, safety and tolerability of Aequus once-daily transdermal formulation containing doxylamine succinate and pyridoxine hydrochloride. In parallel to this study, Aequus is preparing for a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) to define the clinical strategy for regulatory approval in the US. This product is expected to follow a Section 505(b)2 New Drug Application (NDA), 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. Aequus owns the exclusive, worldwide rights to the transdermal formulation for AQS1303 and is committed to deriving the maximum value to shareholders from this program by out-licensing commercial rights in certain markets worldwide.
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