Ketamine Hydrochloride

NASHVILLE, Tenn.--( BUSINESS WIRE )--Melt Pharmaceuticals, Inc. (“Melt”), a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced positive topline results of its pivotal Phase 3 study evaluating the safety and efficacy of its lead product candidate, MELT‑300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery. Based on a Special Protocol Assessment agreement reached with the U.S. Food and Drug Administration (“FDA”) earlier this year, this study design and these positive results support the necessary objectives required for a regulatory submission. MELT-300 uniquely combines a fixed dose of midazolam (3mg) and ketamine (50mg) in one tablet that is administered sublingually using Catalent’s proprietary Zydis ® delivery technology which dissolves in as little as 3 seconds allowing absorption of the active ingredients across the sublingual mucosa. The MELT-300 Phase 3 clinical trial was a randomized, double-blind, three-arm study comparing, at a 4:1:1 ratio, MELT-300, sublingual midazolam, and sublingual placebo, respectively, for procedural sedation in patients undergoing cataract surgery. The study was conducted at 13 clinical sites in the United States and enrolled over 530 patients. In commenting on the topline results, Dr. Larry Dillaha, Chief Executive Officer of Melt, said, “We are extremely excited with this robust topline data from our pivotal Phase 3 study. These overwhelmingly positive results support our belief that MELT-300, if approved by the FDA, would be a safe and effective non-IV, non-opioid alternative to current IV-based cataract surgery sedation protocols, which generally involve the administration of opioids. With the number of cataract surgeries performed each year in the U.S. expected to exceed 5 million in the coming years, we believe offering patients and physicians the ability to achieve an adequate sedation level without the need to start an IV or administer opioids is a very attractive proposition.” MELT-300 co-inventor, Melt Pharmaceuticals board member, and board-certified ophthalmologist John Berdahl, M.D., commented, “A proprietary compounded combination of midazolam and ketamine, which was the inspiration for the development of the MELT-300 product candidate, has been used by hundreds of ophthalmologists, including myself – in hundreds of thousands of cataract surgeries. I am thrilled at the prospect of the FDA approving MELT-300, which I believe would greatly enhance the confidence of healthcare professionals in considering the adoption of this groundbreaking sedation method.” George Magrath, M.D., a board-certified ophthalmologist and a MELT-300 Phase 3 study principal investigator, commented, “These Phase 3 data show the superiority of the combination of midazolam and ketamine compared with midazolam alone. If approved, I believe MELT-300 will be a safe and effective alternative to current sedation methods used for cataract surgery. As an ophthalmologist, I am excited about the prospect of using MELT-300 to enhance the overall experience for my cataract surgery patients.” Dr. Dillaha continued, “In addition to supporting a regulatory submission, these MELT-300 Phase 3 data should further strengthen our already strong patent portfolio, both domestically and internationally. Further, with these data now confirming and complementing our robust Phase 2 efficacy and safety results, we believe we are well positioned to elevate the procedural sedation standard of care for cataract surgery and, through lifecycle management, eventually expand the potential use of MELT-300 to over 100 million annual procedures in various medical specialties, including dermatology, plastic surgery, dentistry, gastroenterology, and emergency care. “Melt Pharmaceuticals is profoundly grateful to the Phase 3 MELT-300 study participants, whose involvement has been invaluable. This includes the ophthalmologists, optometrists, anesthesiologists, certified registered nurse anesthetists, staff, and patients at the 13 U.S. clinical sites.” About Melt Pharmaceuticals Melt Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing proprietary non-IV, non-opioid, sedation, and analgesia therapeutics for human medical procedures in the hospital, outpatient, and in-office settings. Melt intends to seek regulatory approval through the FDA’s 505(b)(2) regulatory pathway for its proprietary, patented small-molecule product candidates, where possible. Melt’s core intellectual property is the subject of multiple granted patents in North America, Europe, Asia, and the Middle East. Melt Pharmaceuticals, Inc. is a former subsidiary of Harrow, Inc. (Nasdaq: HROW) and was carved out as a separately managed business in 2019. To learn more about Melt, please visit their website, www.meltpharma.com . Forward-Looking Statements This press release contains forward-looking statements, which are all statements other than those statements of historical facts. No representation or warranty is made as to such statements, all of which involve substantial risks and uncertainties. Actual results could vary materially.

FDA granted a post-complete letter clarification meeting scheduled for December 2, 2024 Company initiated activities to address the deficiencies cited in the CRL TORONTO, Nov. 19, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the FDA granted a post-complete letter clarification meeting (the “Meeting”) scheduled for December 2, 2024. As previously announced, the Company requested the Meeting in response to the FDA issuing a complete response letter (“CRL”), dated October 22, 2024, for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. The Company has initiated activities to address the deficiencies cited in the CRL. The deficiencies cited in the CRL are classified as MINOR. The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of the ketamine submission batches, which achieved 18 months of stability without issue, and no new preclinical and clinical studies were requested. As noted by the FDA in the CRL, the resubmission to this CRL will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR. The Company will announce a proposed timeline for the resubmission to this CRL after the Meeting and continue to provide updates as they occur. About PharmaTher Holdings Ltd. PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of KETARX™ (Ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, mental health, neurological, and medical countermeasures indications. PharmaTher owns 49% of Sairiyo Therapeutics Inc., which focuses on advancing the clinical development of an improved and patented enteric-coated orally bioavailable formulation of cepharanthine (PD-001) for viral infectious diseases and medical countermeasures. Learn more at PharmaTher.com. For more information about PharmaTher, please contact:Fabio ChianelliChief Executive OfficerPharmaTher Holdings Ltd.Tel: 1-888-846-3171Email: info@pharmather.com Website: www.pharmather.com Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release. Cautionary Statement This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “closer”, "could", “confident”, "would", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim", “may”, “plan”, “proposed”, “lead”, “toward”, “anticipate”, and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in Company's management's discussion and analysis for the three months ended August 31, 2024 dated October 24, 2024, which is available on the Company's profile at www.sedarplus.ca. This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.