M Pharmaceutical Inc (CSNX:MQ, OTCMKTS:MPHMF) is poised to push ahead with its clinical trial plans - after it received a positive response from the powerful US Food and Drug Administration (FDA) for its reformulated slimming product Orlistat.
"The FDA's swift and definitive written response to our Pre-IND submission package provides M Pharma with significant optimism for immediately pushing forward with our plans to initiate clinical trials in 2017," said chief executive Gary Thompson.
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It was assisted with the submission by Camargo Pharmaceutical Services, it said.
Orlistat, or C-103, has been reformulated and the aim is to maintain its proven efficacy while minimizing or eliminating the undesirable side effects.
Recent sales of Orlistat have declined from their peak due to uncomfortable and well-publicized side effects.
Thompson added: "At this exciting and critical stage in the development of C-103, our leadership team and advisory board believe it is prudent and necessary to benefit from Camargo Pharmaceutical 's guidance and expertise.
"This alliance strengthens our efforts to bring C-103 to market, benefitting millions of potential people looking for solutions to reach and maintain a healthy weight," said Thompson.
Ken Phelps, chief executive at Camargo Pharmaceutical Services, added: "We are looking forward to assisting M Pharma in leveraging the successful Pre-IND meeting results and executing a clear path forward by initiating the clinical plan starting this year."
Formed in 2015, M Pharma is developing technologies for obesity, weight management and female health & wellness.
In addition to recent acquisitions of C-103. and assets from 40J's LLC, it is scheduled to launch its FDA cleared fertility product branded as ToConceive sometime in the second quarter of 2017.
Earlier this month, it also said it expects to submit the pre- IND in August this year, with support from Cincinnati based regulatory consultants, on the female sexual dysfunction drug Extrinsa.