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Harrow Health Provides $13.5 Million Senior Secured Loan to Melt Pharmaceuticals
Melt Expects to Dose First Patient in MELT-300 Phase 2 Study During September 2021 NASHVILLE, Tenn.--(BUSINESS WIRE)-- Harrow Health, Inc. (Nasdaq: HROW), an
About this update from Harrow, Inc.
[{"type":"text","content":"\nMelt Expects to Dose First Patient in MELT-300 Phase 2 Study During September 2021\n\n NASHVILLE, Tenn.--(BUSINESS WIRE)--\nHarrow Health, Inc. (Nasdaq: HROW), an ophthalmic-focused healthcare company, and Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing first-in-class medicines for sedation and analgesia, today announced that Harrow Health has provided a $13.5 million senior secured loan to Melt Pharmaceuticals.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210902005101/en/\nMelt Pharmaceuticals plans to use the proceeds to conduct its pivotal Phase 2 efficacy study for the company’s lead drug candidate, MELT-300, a patented combination of midazolam and ketamine in a rapidly dissolving, sublingual tablet to provide sedation and analgesia for patients undergoing cataract surgery. Melt’s IV-free and non-opioid approach seeks to replace the current practice of IV-delivered sedation and analgesia medication, including the use of fentanyl intraoperatively and other opioids prescribed for pain post-operatively. Melt expects to dose its first patient in September 2021 and to report topline clinical results in the spring of 2022. Pending the outcome of the Phase 2 clinical study, Melt Pharmaceuticals anticipates beginning a Phase 3 clinical study, which compares MELT-300 to a placebo, in the second half of 2022. Melt also expects to file with the U.S. Food and Drug Administration (FDA) two investigational new drug applications (INDs) for its MELT-210 and MELT-400 programs in the latter part of 2021.\n\n“We are pleased to have secured this non-dilutive funding that allows us to complete our Phase 2 clinical study of MELT-300 and execute our overall clinical strategy, which we expect to generate data to ultimately support a new drug application (NDA) submission to the FDA,” said Larry Dillaha, M.D., CEO of Melt Pharmaceuticals. “Recent estimates are that as many as 50% of the over four million annual cataract surgeries in the U.S. involve patients being exposed to opioids perioperatively. If FDA approved, MELT-300 will be a new surgical protocol that should virtually eliminate opioid exposure during cataract surgery, ameliorating, in part, the devastating public health effects of the U.S. opioid crisis. As a result of this funding, we will now...