Palm Beach, FL – November 20, 2019 – It appears that the reign of the opioid drugs in the global pain management markets could be coming to an end. While opioids have long been the ‘best’ choice to address the pain patients suffer from various ailments, there has been a growing focus on non-opioid drugs, therapies and devices. Recent reports and studies, like one published by ResearchAndMarkets, says that the current market is gradually adopting more non-opioid medications to suppress the addiction toward opioids and certain well-established painkillers in the market. There are several non-opioid drugs with mechanisms of action that are currently in early and late-stage development. The federal authorities in multiple countries are shifting to alternative approaches, and thus, fast-tracking those drugs to market approval. The shift is expected to be gradual, and thus pain management has very attractive growth prospects between 2019 and 2024. Active biotech and pharma companies in the markets this week include: Q BioMed Inc. (OTCQB: QBIO), Myovant Sciences Ltd. (NYSE: MYOV), Heron Therapeutics, Inc. (NASDAQ: HRTX), BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX), Endo International plc (NASDAQ: ENDP).
The report said: “The growth of the global pain management drugs and devices market is majorly due to the well-established business of painkiller medications as the first line of treatment. In recent years, the increasing reliance on their prolonged use and a greater understanding of their side-effects have led to the growing use of device-based pain management therapies. Presently, at the country level, economic factors play a significant role in the management of financial implications for hospitals. Postsurgical pain is one of the primary focuses of hospitals, where the cost of monitoring and the treatment of adverse effects creates the major demand for pain management drugs and devices.”
Q BioMed Inc. (OTCQB:QBIO) BREAKING NEWS: Q BioMed Announces FDA Approval – Q BioMed announces FDA approval of its contract manufacturer IsoTherapeutics Group LLC (ITG). ITG is now cleared to manufacture the Company’s FDA approved non-opioid cancer bone pain drug Strontium-89 Chloride USP.
The long-awaited approval of the facility means that this important oncologic pain drug will soon be available to patients in the US and the rest of the world. Q BioMed is now the only FDA-approved source for this drug in the western world. The Company is activating its planned commercial operations to support marketing, sales, and distribution in the US and, soon, in the rest of the world.
Strontium-89 is an FDA-approved non-opioid radiopharmaceutical indicated for the treatment of painful skeletal metastases caused by cancer. The product is administered intravenously once every three months as an alternative to opioid analgesics and plays a critical role in the treatment of metastatic bone pain.The product has a long history of providing well-documented and significant pain relief for patients suffering from the excruciating pain associated with primary cancers that have spread to the bone, including breast, prostate, lung and others. This is the ideal time to be launching Strontium-89 given the current concerns with the over-use of opioid drugs. In addition, as more therapies come to market for the treatment of primary cancers, more people are living longer with metastatic disease. It is estimated that approximately two million patients experience debilitating bone pain from metastatic disease. The opportunity to provide significant pain relief to this group is substantial.
QBioMed CEO Denis Corin said, “We have been anticipating this critical regulatory step for a long time, certainly longer than we hoped, but we are thrilled that we can now move forward with certainty. This is the start of a new chapter in the evolution of our company, and we are looking forward to serving the needs of thousands of patients suffering from metastatic bone pain, providing them the chance to minimize their pain and positively impact life with metastatic disease. With millions of potential patients around the world, this is a major market opportunity for our company. In addition, we are investigating and planning expansion trials to provide additional indications for the drug and entry into an even larger therapeutic market.” Read this entire release and more news for QBIO at: https://financialnewsmedia.com/news-qbio/
Other recent developments in the biotech industry include:
Myovant Sciences Ltd. (NYSE: MYOV) recently announced that the Phase 3 HERO study of once-daily, oral relugolix (120 mg) met its primary efficacy endpoint and all six key secondary endpoints in men with advanced prostate cancer. These results support a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the second quarter of 2020 and future regulatory submissions in Europe and Japan.
“An oral gonadotropin-releasing hormone, or GnRH, antagonist for advanced prostate cancer has been an aspiration for many years,” said Neal Shore, M.D., Medical Director of the Carolina Urologic Research Center and HERO Program Steering Committee Member. “If approved, relugolix would become the first-of-its-kind oral option for men with advanced prostate cancer.”
Heron Therapeutics, Inc. (NASDAQ: HRTX) recently announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain. The FDA set a PDUFA goal date of March 26, 2020.
“HTX-011 was designated by the FDA as a Breakthrough Therapy for postoperative pain management and has the potential to be an important new pain management option for patients, which has been shown in Phase 3 clinical trials to significantly reduce postoperative pain, including severe pain, and to significantly reduce the need for opioids,” said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. “The recently reported topline results from Study 306 in patients undergoing knee replacement surgery who received HTX-011 as part of a common multimodal analgesic regimen showed that patients maintained an average pain score in the mild range for 72 hours after surgery with only 25% receiving a prescription for opioids upon hospital discharge. These results provide additional evidence that even in large painful surgical procedures HTX-011 can help to reduce both pain and the amount of opioid pills going out into society.”
BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) recently announced 48-week results from its APeX-S and APeX-2 trials and comprehensive market research which support the significant commercial opportunity for oral, once daily BCX7353 in HAE.
“The 48-week clinical trial data we now have from APeX-S and APeX-2 highlight the control patients are having over their attacks with oral, once daily BCX7353, and consequently why 75 percent of patients stayed on-study through 48 weeks when they had other choices,” said Jon Stonehouse, chief executive officer of BioCryst.
Endo International plc (NASDAQ: ENDP) announced recently that the U.S. Food and Drug Administration (FDA) has accepted for review the original Biologics License Application (BLA) for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks. The Prescription Drug User Fee Act (PDUFA), or target action date for the BLA, has been set for July 6, 2020 .
“We have confidence in and are excited by the promising results of our CCH for cellulite program, which encompasses the largest U.S. clinical trials for the treatment of cellulite in history1,” said Paul Campanelli , Endo’s Chairman, President and Chief Executive Officer. “Acceptance of our BLA is a significant milestone and we look forward to advancing the next steps to bring this treatment to aesthetic physicians and their patients.”
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