Quay Pharma has developed a specialised filling system to enable a new treatment for anorectal diseases to enter Phase III clinical trials
The company which provides a full range of services enabling clients to bring drug products through the various stages of clinical trials, developed the Capository from RDD Pharma, as a proprietary delivery system for the precise delivery of drugs that target conditions and diseases of the anorectal region.
It allows directly controlled and precise application of medication to the anal canal region. The company has completed recruitment of a pivotal European Phase III study in chronic anal fissure.
Prior to Quay’s involvement, the only solution available to fill the drug into the Capository was manually. This would have been an extremely slow process as 70,000 units were required for the initial trials.
The team at Quay worked to develop a suitable filling process that would allow for accuracy, speed, efficiency and reproducibility.
Quay Pharma has delivered in excess of 40,000 Capositories to support RDD’s clinical development programmes. Looking to the future, RDD is planning on running a second Phase III study to support US registration of the Capository.
“The Capository provides an elegant solution to treat pain associated with anal fissure,” explains Jason Laufer of RDD Pharma.
The Phase IIa study showed a statistically significant reduction in fecal incontinence with one daily topical treatment.
“Quay Pharma has been instrumental in helping us move this exciting clinical development forward.”