Business
Filing of Patents and Sildenafil Update
Filing of Patents and Sildenafil Update.
About this update from Thalia Therapeutics Plc
[{"type":"text","content":"\n \nRNS Number : 0666F N4 Pharma PLC 15 May 2017 \n\n15 May 2017\nN4 Pharma Plc\n(\"N4 Pharma\" or the \"Company\")\nFiling of Patents and Sildenafil Update\nN4 Pharma Plc (AIM: N4P), a specialist pharmaceutical company which reformulates existing drugs and vaccines to improve their performance, is pleased to announce the filing of its Patent Cooperation Treaty (\"PCT\") patent application for its sildenafil reformulation and provide an update on the work done by the Company in the year to date as it moves towards clinical trials. In addition, the Company is pleased to announce the filing of two new patents expanding its potential reformulation product pipeline to five.\nSildenafil Update\nSince the start of this year, work has continued on the Company's sildenafil reformulation and the Company has now filed its PCT patent application seeking worldwide protection of the Company's reformulation methodology. This follows the successful completion of the laboratory dissolution testing of the formulation to establish the correct dissolution profile required for the reformulated product.\n \nThe next phase for the sildenafil product is to move into clinical trials with healthy volunteers to determine the precise level of the drug in blood plasma to then take those results to the relevant regulatory authorities, such as the Food and Drug Administration (\"FDA\") in the USA and the Medicines and Healthcare Regulatory Agency (\"MHRA\") in the UK. The Company is in the process of discussing the parameters for these trials as well as working through all the regulatory requirements and necessary approvals before they can formally commence and will make further announcements in due course as and when the timing of commencement of the trials becomes clearer. \n \nNew Product Patent Filings \n \nN4 Pharma has also filed two new patent applications in respect of the reformulation of two other drugs. \n \nThe first is for a reformulation of the anti-depressant drug, paroxetine, to develop a new product for the treatment of hot flashes and night sweats in menopausal women. Paroxetine has already been approved for these treatments by the FDA.\n \nThe second is for a reformulation of another anti-depressant drug, duloxetine, for the treatment of premature ejaculation (\"PE\"). This product differs slightly to our st...