RDD is initiating a Phase 3 study for treatment of chronic anal fissure with RDD 1219, with a novel sustained release drug-delivery device — the Capository™. This product has numerous competitive advantages over the one marketed product for this indication. The anal fissure market is anticipated to reach $5-600M.
RDD recently completed a successful Phase 2a study of RDD 0315 in fecal incontinence, which reached the primary endpoint (lowered frequency of incontinence events). There are no approved therapies for this indication. Fecal incontinence market has the potential to approach $3B in sales.
Molecules in development are expected to reach the market in 2 to 6 years, and occupy a lucrative niche between generics and New Chemical Entities (NCEs).