Aequus moves forward in studying transdermal aripiprazole patch
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Aequus recently announced completion of dosing in its second proof-of-concept clinical trial for AQS1301, a once-weekly transdermal patch for aripiprazole.
AQS1301 is designed as a simple and convenient long-acting alternative to the once-daily oral aripiprazole pill.
The 28-day multi-dose study was supported by a grant from the National Research Council of Canada Industrial Research Assistance Program for up to $100,000.
“We look forward to announcing the results of this study, which we expect will provide a solid basis for advancing AQS1301 through an initial meeting with the FDA regarding the clinical path to approval in the United States, as well as continued advancement in partnership discussions for this program,” Anne Stevens, BSc, MHA, chief operating officer and director of Aequus, said in a press release “The single-dose exposure study previously completed in 2016 demonstrated the potential for our formulation to provide sustained and controlled delivery of aripiprazole over seven days in therapeutic doses. This study will provide information that will enable us and our development partner, Corium International, to finalize the design of the transdermal patch that we would advance into late stage clinical studies.”
Aequus expects to report study results in the first quarter of 2017.
Following that, the company plans to meet with the FDA for a pre-Investigational New Drug discussion.