RDD Pharma, a leader in developing treatments for anorectal disorders, has announced the European Medicines Agency's Committee for Orphan Medicinal Products has granted orphan designation for RDD-0315, an investigational drug for the treatment of fecal incontinence in patients with spinal cord injury. The committee recognized that RDD-0315 may be of significant benefit to spinal cord injury patients affected by fecal incontinence.
"We are pleased the EMA recognized the clinically significant benefit that RDD-0315 may offer spinal cord injury patients," stated Jason Laufer, chief executive officer, RDD Pharma. 'We have the potential to positively impact the health, well-being and quality of life in this patient population. '
The Orphan Designation provides potential incentives from the European Union to develop a medicine with a prevalence of less than 5 in 10,000, such as protocol assistance, reduced fees, funding from the European Commission for clinical trials, and protection from competition once the medicine is placed on the market, including 10 years of market exclusivity.
Positive Phase 2a results in evaluating the safety and efficacy of RDD-0315 for the treatment of fecal incontinence in spinal cord injury patients have previously been reported with a statistically significant reduction in the number of fecal incontinence episodes at 8 and 12 hours post-administration.
"We are thrilled with the EMA's recognition of positive results seen in our phase 2a study and the potential of a treatment such as RDD-0315 for patients who suffer from fecal incontinence," said Nir Barak, Chief Medical Officer of RDD Pharma. "We look forward to advancing our studies in the EU and to filing an IND with the US Food and Drug Administration later this year."
Ema grants orphan drug, rdd pharma's rdd-0315, treat fecal incontinence, patients with spinal cord injury
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