Rho to support NDA for Evoke Pharma’s patented nasal spray
The regulatory consulting and contract research organization (CRO) will prepare and submit a 505(b)(2) New Drug Application (NDA) for Gimoti, a patented nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus.
Rho is a privately-held CRO located in Chapel Hill, NC and provides a range of clinical research services across the drug development process.
"Evoke is very pleased to have Rho on board to assist the Company with the preparation and submission of its planned 505(b)(2) New Drug Application (NDA) for Gimoti," Dave Gonyer, R.Ph. president and CEO of Evoke Pharma told Outsourcing-Pharma.com.
"The next step for the company is to launch its comparative exposure pharmacokinetic (PK) study for Gimoti which will be conducted by Spaulding Clinical Research and may provide the final data needed for the NDA," he said.
The Wisconsin-based CRO operates a 200-bed clinical pharmacology unit, cardiac core laboratory, and provides biometrics/scientific affairs services.
The PK study is planned for the second half of the year with an NDA submission expected by late 2017 or early 2018.
