R&D Methodology

Establishing safety, efficacy, scalability and commercial viability of new drug candidate requires commitment of substantial resources over years time. Successfully substantiating these factors mitigates key risks associated with developing new drugs, before initiating costly phase III and toxicology studies, while increasing the probability of successful clearance and commercialization.   
Se-cure’s botanical drugs development methodology, relies on significant OTC sales, before approaching the FDA’s clearance path. In fact, OTC commercialization is initiated as early as successful completion of safety valuation and pre-clinical studies in a drug candidate. The botanical drug candidates are distributed in selected territories, within a multi-year, multi-ethnicity pilot program. This program addresses interrelating aspects of the new drug candidate, including: safety, clinical, technological, manufacturing, quality controls, marketing and intellectual property.  As part of the OTC program, Phase IV equivalent post marketing surveillance studies are carried out with physicians and users of the drug candidates, to monitor compliance and adverse events.

The methodology is aimed to advance botanical drug candidates to Phase III study, as mature, proven safe and effective, scalable as well as commercially viable. The program also allows for accumulating substantial treatment history, for example, Se-cure’s flagship botanical complex DT56a, branded as Femarelle®, achieved over 2.5 million months of treatment history when admitted by the FDA to enter phase III study.

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