Technological intervention is gaining exceptional pace in medical and healthcare realms owing to their superior outcome and minimal likelihood of human errors. IN this light, companies are increasingly focusing on achieving highest breakthroughs in new therapeutic development such as drug delivery system to ensure maximum patient satisfaction and favorable outcome. In novel drug innovation international approvals play a crucial role, such as the FDA approval system whenever there is a new drug hitting the market.
To cite an instance, Tolmar Pharmaceuticals has made recent announcements about the FDA approvals that it has bagged for new drug candidate, Fensolvi which is a compound of leuprolide acetate. The discovery is envisioned to be used in full potential as am injectable suspension to treat the critical yet rare condition of central precocious puberty (CPP) that induces premature puberty amongst both sexes, starting at age eight for the fairer sex, and nine for the boys. IN contemporary times leuprolid acetate has been serving as the most potent and largely used chemical suspension to treat the rare condition of CPP. IN Fensolvi, Tolmar Pharmaceuticals has aimed to use a flagship polymeric gel technology that contains the chemical compound in a solidified state, regulating its timely release in a well-controlled manner gradually at regular intervals. The current dosage is miniature, of about 0,375mL, which is then followed by a successive dosage after conclusion of six months.
In the words of Stuart Atkinson, the clinical success and FDA approval of Fensolvi is highly advantageous for the company and would in the long rum revolutionize CPP therapeutics in multiple ways. He further added the unique advantages and product feature developments such as subcutaneous administration, miniature dosage and gap of at least six months are prominent advantages that have fetch Fensolvi its due treatment as a promising CPP drug formulation.
The extensive FDA approval system for Fensolvi is based on open label single arm multicenter evaluation at phase 3 clinical study which advocate the safety and accuracy of pharmacokinetics leuprolide acetate used currently for a clinical study on 64 children, that eventually fetched favorable results.