{"id":5420,"date":"2024-02-06T01:35:01","date_gmt":"2024-02-06T01:35:01","guid":{"rendered":"https:\/\/economicherald.net\/?p=5420"},"modified":"2024-02-06T01:35:01","modified_gmt":"2024-02-06T01:35:01","slug":"asx-health-stocks-ltp-is-recruiting-for-patients-to-try-its-erection-spray","status":"publish","type":"post","link":"https:\/\/economicherald.net\/?p=5420","title":{"rendered":"ASX Health Stocks: LTP is recruiting for patients to try its erection spray"},"content":{"rendered":"<p>LTR Pharma to commence clinical study on SPONTAN<br \/>\nAFT\u2019s Maxigesic IV launched in the US<br \/>\nAllegra won\u2019t pursue FDA submission, will sell assets instead<\/p>\n<p>\u00a0<\/p>\n<h2>LTR Pharma to take SPONTAN to clinic<\/h2>\n<p><strong><a href=\"https:\/\/stockhead.com.au\/company\/ltr-pharma-ltp\/\">LTR Pharma (ASX:LTP)<\/a><\/strong> announced that it has achieved manufacturing validation for its upcoming pivotal clinical study for its lead product, <strong>SPONTAN.<\/strong><\/p>\n<p>All essential criteria for the pivotal <strong>FDA clinical study<\/strong> have been met \u2013 including stability testing, quality control checks, product purity and packaging integrity.<\/p>\n<p>By testing the chemical stability of SPONTAN over three specified periods, whilst assessing packaging integrity and confirming purity of the active ingredients, LTR Pharma has now met key US FDA requirements to be considered a pivotal study.<\/p>\n<p>LTR Pharma <strong>chairman, Lee Rodne<\/strong>, said this achievement has been underpinned by a comprehensive suite of quality control checks as mandated by the FDA.<\/p>\n<p>\u201cEach check was meticulously designed to evaluate the chemical stability of SPONTAN over specified time periods, assess the integrity of its packaging, and verify the purity of our nasal spray formulation,\u201d said Rodne.<\/p>\n<p>\u201cWe are optimistic about the potential impact of SPONTAN in the market and look forward to sharing our progress as we move closer to initiating the clinical trial.\u201c<\/p>\n<p>Patient recruitment for the bioequivalence study is now due to commence this month.<\/p>\n<p>SPONTAN is an innovative nasal spray treatment for erectile dysfunction. The nasal cavity is a highly vascular part of the body supporting even and rapid absorption of the drug, empowering it to work within 10 minutes or less.<\/p>\n<p>\u00a0<\/p>\n<h2>AFT Pharma launches Maxigesic IV in the US<\/h2>\n<p><strong><a href=\"https:\/\/stockhead.com.au\/company\/aft-pharmaceuticals-afp\/\">AFT Pharmaceuticals (ASX:AFP)<\/a><\/strong> announced that <strong>Maxigesic IV<\/strong>, the patented intravenous form of pain relief medicines, has today been launched in the US by its licensee, <em>Hikma Pharmaceuticals<\/em>.<\/p>\n<p>The launch of the medicine, under the brand <strong>Combogesic IV<\/strong>, is the first patented, NZ-developed medicine with clinical studies in the world\u2019s largest healthcare market.<\/p>\n<p>The first commercial sale of the medicine in the US is expected in the coming weeks, a milestone that will <strong>trigger a US$6 million licensee fee to AFT<\/strong>.<\/p>\n<p>AFT expects its share of this licence fee to accrue in the current financial year.<\/p>\n<p>Maxigesic IV has been billed as a significant innovation for the management of pain, offering effective pain relief as well as an alternative to opioid analgesics.<\/p>\n<p>\u201cThe launch also represents a beachhead for the commercialisation of Maxigesic in the US and potentially our broader portfolio of medicines,\u201d said <em>AFT co-founder and CEO, Dr Hartley Atkinson.<\/em><\/p>\n<p>\u201cOur next goal is the finalisation of plans to launch Maxigesic Rapid, a prescription-only tablet. We have been working on setting up AFT representation in North America in order to support commercialisation with identified partners.\u201d<\/p>\n<p>\u00a0<\/p>\n<h2>Is this the end for Allegra?<\/h2>\n<p><strong><a href=\"https:\/\/stockhead.com.au\/company\/allegra-orthopaedics-amt\/\">Allegra Medical Technologies (ASX:AMT)<\/a><\/strong> has taken the decision to <strong>not proceed with its formal submission to the US FDA<\/strong> as previously planned.<\/p>\n<p>The decision was taken following recent communication with the FDA, resulting in Allegra recognising the need for additional information to support its submission.<\/p>\n<p>Following that communication, Allegra has opted to voluntarily withdraw its submission to the FDA.<\/p>\n<p>Allegra said its limited working capital and the additional expense required in obtaining that supporting data meant that an FDA submission was not feasible.<\/p>\n<p>Allegra has now thoroughly explored all available options, and after careful consideration, the preferred option is to go to the market to seek a buyer for all of its intellectual property relating to the Sr-HT-Gahnite and Sr-HT.<\/p>\n<p>This includes worldwide patents and all registered patents and application for patents in relation to the bio ceramic material, including the spinal fusion cage.<\/p>\n<p>Undertaking this process and any subsequent sale will be subject to the required ASX and regulatory approvals.<\/p>\n<p>\u00a0<\/p>\n<h2>Share prices today:<\/h2>\n<p>\u00a0<\/p>\n\n<p><span class=\"mce_SELRES_start\">\ufeff<\/span><span class=\"mce_SELRES_start\"><\/span>\u00a0<br \/>\n<span class=\"et_bloom_bottom_trigger\"><\/span><\/p>\n<p>The post <a href=\"https:\/\/stockhead.com.au\/health\/asx-health-stocks-ltp-is-recruiting-for-patients-to-try-its-erection-spray\/\">ASX Health Stocks: LTP is recruiting for patients to try its erection spray<\/a> appeared first on <a href=\"https:\/\/stockhead.com.au\/\">Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>LTR Pharma to commence clinical study on SPONTAN AFT\u2019s Maxigesic IV launched in the US Allegra won\u2019t pursue FDA submission, will sell assets instead \u00a0 <a href=\"https:\/\/economicherald.net\/?p=5420\" class=\"read-more-link\">[more&#8230;]<\/a><\/p>\n","protected":false},"author":0,"featured_media":5421,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-5420","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-finance"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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