Fedovapagon is in clinical development as an oral treatment for nocturia in men with benign prostate enlargement. Nocturia is a common symptom in men who have enlarged prostates. Nocturia is generally defined as excessive or disruptive (either due to the volume of urine or frequency of trips to the toilet) night-time urination which disrupts sleep and impairs quality of life. There are currently no specific treatments for nocturia in men with enlarged prostates. Instead, nocturia is currently managed with drugs prescribed to treat the general symptoms of enlarged prostates, which are rarely effective in treating nocturia and can have side effects. As this is a common symptom in men with this condition, there is a clinical need for this type of treatment.
Fedovapagon works directly in the collecting ducts of the kidney by binding to, and activating receptors that causes the kidneys to reabsorb water from urine as it passes towards the bladder. If fedovapagon is administered before going to bed the result is less urine produced overnight. Therefore, if licensed, fedovapagon would be the first medicinal product specifically for the treatment of nocturia in men with enlarged prostates.
Difelikefalin is a potent kappa opioid receptor agonist that is an itch and inflammation suppressant. Difelikefalin intravenous injection acts as an itch and inflammation suppressant without the undesirable side-effects typical of a centrally-acting opioid medicine such as hallucinations or opioid addiction. If licensed, difelikefalin will offer an additional treatment option for adult haemodialysis patients with moderate to severe CKD-aP who currently have few effective therapies available.