Results of pivotal study confirm bioequivalence and good oral
tolerability of sublingual sildenafil wafer (PheoniX) when compared with
reference drug
Singapore, 13 September 2016 – Homegrown specialty pharmaceutical company iX Biopharma Ltd. (“iX Biopharma” or, together with its subsidiaries, “the Group”) is pleased to announce the positive results of a pivotal bioequivalence study comparing iX Biopharma’s novel sildenafil wafer (PheoniX) with the reference drug (in this instance the oral tablet, Viagra®). Sildenafil is the active compound in both PheoniX and the reference drug and is used in the treatment of male erectile dysfunction.
The study compared the pharmacokinetics (i.e., absorption, distribution, metabolism and elimination) of sildenafil between PheoniX and the reference drug. The study achieved its primary objective by demonstrating that the sublingual wafer formulation of PheoniX had a similar rate and extent of drug absorption as the reference drug. PheoniX was well-tolerated and there were no serious adverse events reported.
Dr Janakan Krishnarajah, Chief Medical Officer said, “We are very pleased that the study demonstrated bioequivalence between PheoniX and the reference drug. We are excited to reach this important milestone for PheoniX which brings iX Biopharma closer to delivering our novel WaferiX technology to the market. On the back of this positive results, the Group will proceed to apply for registration of PheoniX with the Therapeutic Goods Administration (TGA) in Australia.”
PheoniX is Halal-certified and one of several other drugs in iX Biopharma’s product pipeline. Other products under development include Wafermine and BnoX for pain management, and WafeRest for improved sleep quality.
About iX Biopharma Ltd
iX Biopharma Ltd is a Singapore public-listed specialty pharmaceutical company, with manufacturing and laboratory testing facilities in Australia. The Group is focused on the development and commercialisation of innovative therapies for improving the quality of life of those suffering from pain and other health issues. The Company leverages its patented sublingual drug delivery technology, WaferiX, to develop proprietary products that incorporate pharmacologically active compounds that have been approved by the United States Food and Drug Administration. Its pipeline of products under development includes Wafermine and BnoX for pain management, PheoniX for erectile dysfunction, and WafeRest for improved sleep quality.
Singapore, 13 September 2016 – Homegrown specialty pharmaceutical company iX Biopharma Ltd. (“iX Biopharma” or, together with its subsidiaries, “the Group”) is pleased to announce the positive results of a pivotal bioequivalence study comparing iX Biopharma’s novel sildenafil wafer (PheoniX) with the reference drug (in this instance the oral tablet, Viagra®). Sildenafil is the active compound in both PheoniX and the reference drug and is used in the treatment of male erectile dysfunction.
The study compared the pharmacokinetics (i.e., absorption, distribution, metabolism and elimination) of sildenafil between PheoniX and the reference drug. The study achieved its primary objective by demonstrating that the sublingual wafer formulation of PheoniX had a similar rate and extent of drug absorption as the reference drug. PheoniX was well-tolerated and there were no serious adverse events reported.
Dr Janakan Krishnarajah, Chief Medical Officer said, “We are very pleased that the study demonstrated bioequivalence between PheoniX and the reference drug. We are excited to reach this important milestone for PheoniX which brings iX Biopharma closer to delivering our novel WaferiX technology to the market. On the back of this positive results, the Group will proceed to apply for registration of PheoniX with the Therapeutic Goods Administration (TGA) in Australia.”
PheoniX is Halal-certified and one of several other drugs in iX Biopharma’s product pipeline. Other products under development include Wafermine and BnoX for pain management, and WafeRest for improved sleep quality.
About iX Biopharma Ltd
iX Biopharma Ltd is a Singapore public-listed specialty pharmaceutical company, with manufacturing and laboratory testing facilities in Australia. The Group is focused on the development and commercialisation of innovative therapies for improving the quality of life of those suffering from pain and other health issues. The Company leverages its patented sublingual drug delivery technology, WaferiX, to develop proprietary products that incorporate pharmacologically active compounds that have been approved by the United States Food and Drug Administration. Its pipeline of products under development includes Wafermine and BnoX for pain management, PheoniX for erectile dysfunction, and WafeRest for improved sleep quality.
