Uncontrollable and extreme muscular spasm in the anal canal reduces blood flow to the lining of the anus, resulting in tissue ischemia, formation of chronic fissures, bleeding, and severe pain. Relaxation of the muscular spasm via topical application of spasmolytics (nitroglycerin, diltiazam, nifedipine) relieves pain and improves regional blood flow, thus enabling the healing process to commence. Innovation- RDD Pharma Ltd has developed a Nifedipine Cappository that prevents anal muscle spasm equivalent to the effect of Nitroglycerin products. A Phase 2 pilot study of the Nifedipine Cappository demonstrated dramatic relief of pain and healing of anal fissures in 20 patients, effects that were superior to the activity of currently registered products.
According to the National Spinal Cord Injury Statistical Center, in 2010, there were 265,000 SCI patients in the US. Survey among SCI patients revealed that 75% of them report FI, and 37% of the use diapers because of FI. Therefore, in the US there are about 100,000 SCI patients in need for treatment for the management of FI. Innovation- Alpha-2 is an adrenomimetic that agonizes Alpha-1 and Alpha-2 adrenergic receptors. Alpha-2 has been used worldwide for the treatment of other conditions.
Biological Target- RDD Pharma found that intra-anal application of Alpha-2, cause a significant and long lasting contraction of the anal sphincter: in a study in healthy humans, intra-anal Alpha-2 was compared to two intra-anal doses of Phenylephrine. While both products showed similar increase in resting anal pressure, this change lasted for more than 6 hours with Alpha-2, whereas with Phenylephrine it lasted for less than 3 hours,, thus proving the clinical effectiveness and superiority of Alpha-2
Pruritus ani (also known as anusitis) is the irritation of the skin at the exit of the rectum, known as the anus, causing the desire to scratch. At worst, anal itching causes intolerable discomfort that often is accompanied by burning and soreness. It is estimated that up to 5% of the population of the United States experiences this type of discomfort daily. If the itchiness is secondary to another condition such as infection or psoriasis these are typically treated. For pruritus ani of unknown cause treatment typically begins with measures to reduce irritation and trauma to the perianal area. Stool softeners can help prevent constipation. If this is not effective topical steroids or injected methylene blue may be tried. Innovation- repurposing of an oral medication for the treatment of idiopathic pruritus ani
RDD Pharma is a drug-device company that developed an intra-anal drug delivery device that delivers a drug to the anal canal in a controlled manner.
The company utilizes a high-reward low-risk business model by repurposing drugs; By choosing medications that are already approved for other indications and combining them into our proprietary* drug-delivery technology, we benefit from short regulatory route while maintaining our patent protection.