VANCOUVER, British Columbia, March 07, 2018 (GLOBE NEWSWIRE) -- Aequus Pharmaceuticals Inc. (TSX-V:AQS) (OTCQB:AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that the Company has received confirmation from the US Food and Drug Administration (“FDA”) that they will be providing feedback to the Company’s pre-Investigational New Drug (“pre-IND”) submission by the end of April, 2018 to define the clinical strategy for regulatory approval in the US for AQS1303.
Aequus’ long-acting transdermal anti-nausea patch, AQS1303, contains the combination of pyridoxine and doxylamine (the active ingredients in Diclegis ®/Diclectin ®). AQS1303 is designed to 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.
The 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 global rights to this program, and will look to find a strategic partner to advance towards commercialization in major markets.
The Company issued Camargo Pharmaceutical Services, LLC 59,038 common shares on March 7, 2018 in connection with this milestone regulatory event as per a previously announced service agreement to provide regulatory consulting services for the Company’s product development programs in the United States.
ABOUT AEQUUS PHARMACEUTICALS INC.
Aequus Pharmaceuticals Inc. (TSX-V:AQS, OTCQB:AQSZF) is a growing specialty pharmaceutical company focused on developing and commercializing high quality, differentiated products. Aequus’ development stage pipeline includes several products in neurology and psychiatry with a goal of addressing the need for improved medication adherence through enhanced delivery systems. With a focus in neurology and other specialty areas, our most recent addition to the development pipeline was a long-acting form of medical cannabis, where there is a high need for a consistent, predictable and pharmaceutical-grade delivery of products for patients. Aequus intends to commercialize its internal programs in Canada alongside its current portfolio of marketed established medicines and will look to form strategic partnerships that would maximize the reach of its product candidates worldwide. Aequus plans to build on its Canadian commercial platform through the launch of additional products that are either created internally or brought in through an acquisition or license; remaining focused on highly specialized therapeutic areas. For further information, please visitwww.aequuspharma.ca.
ABOUT CAMARGO PHARMACEUTICAL SERVICES, LLC.
Camargo Pharmaceutical Services is the most experienced team of experts providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory, and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure Agency buy-in every step of the way. With alignment through pre-Investigational New Drug (pre-IND) meeting planning and preparations, Camargo maintains and ensures consistency throughout the drug development program, which increases the likelihood of NDA and future market success. Routinely holding three to six pre-IND meetings a month, Camargo works with product developers across more than 25 countries. For more about Camargo Pharmaceutical Services, visit http://camargopharma.com