PALM BEACH, Florida, March 16, 2018 /PRNewswire/ --
MarketNewsUpdates.com News Commentary
Accordingto BCC Research Report, the global market for non-opioid pain treatment totaled $9.9 billion in 2017 and is estimated to reach $22.6 billion by 2022, growing at a compound annual growth
Q BioMed Inc. (OTCQB: QBIO) BREAKING NEWS: Q BioMed Inc., a commercial stage biotechnology acceleration development company, and Bio-Nucleonics, licensor of Strontium 89 Chloride, announce submission of a regulatory filing to the FDA for the approval of a new manufacturing facility. Upon approval by the FDA, the facility will be permitted to manufacture Strontium Chloride Sr89 Injection USP (Strontium-89) in accordance with cGMP.
Strontium-89 is a non-opioid injectable radiopharmaceutical to relieve cancer bone pain in patients with painful skeletal metastases. In the body, strontium acts similar to calcium, selectively localizing in bone and is preferentially taken up in osteoblastic lesions. The unabsorbed isotope clears rapidly from the blood and is excreted in the urine the first 2 to 3 days following injection. Uptake of Strontium-89 occurs preferentially in sites of active osteogenesis; thus bone tumors and areas of metastatic involvement (blastic lesions) can accumulate significantly greater concentrations of Strontium-89 than surrounding normal bone.
Strontium-89 is a pure beta emitter, and selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation of soft tissues distant from bone lesions. The presence of bone metastases should be confirmed prior to therapy. When blastic osseous metastases are present, significantly enhanced localization of the radiopharmaceutical will occur with corresponding higher doses to the metastases compared with normal bones and other organs. Although responses can vary, pain relief typically begins 7 to 20 days after injection and lasts for four months or more.. Read this and more news for Q BioMed at: http://www.marketnewsupdates.com/news/qbio.html
In other biotech industry developments of note:
Sorrento Therapeutics, Inc. (NASDAQ: SRNE) ("Sorrento"), and its majority-owned subsidiary, Scilex Pharmaceuticals Inc. ("Scilex"), received approval from the U.S. Food and Drug Administration (FDA) for ZTlido™ (lidocaine topical system) 1.8%. ZTlido is indicated for the relief of pain associated with post-herpetic neuralgia (PHN), also referred to as post-shingles pain. ZTlido is a major advancement in analgesics because of its proprietary adhesion technology demonstrating 12-hour wear with efficient lidocaine delivery, even during exercise. "ZTlido was designed to solve a problem that is commonly reported with transdermal/topical patches: they don't stay on. Based on the adhesion study results with ZTlido, we believe that ZTlido product will be welcomed by healthcare providers, patients and payers who are looking for an effective and efficient, local pain treatment," said Dr. Henry Ji, Chairman and CEO of Sorrento and Scilex.
Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) recently announced positive results of a Phase 2 study of the NaV1.8 inhibitor VX-150 in patients with acute pain following bunionectomy surgery. Treatment with VX-150 showed statistically significant relief of acute pain compared to placebo, as determined by the time-weighted Sum of the Pain Intensity Difference over the first 24 hours of treatment (SPID24), a standard measure of acute pain relief. The study also included a standard-of-care reference arm of the commonly prescribed opioid medicine hydrocodone+acetaminophen to support the evaluation of a potential treatment effect for VX-150. VX-150 was generally well tolerated, and there were no discontinuations for adverse events in any arm of the study.
DURECT Corporation (NASDAQ: DRRX) recently announced that its licensee, Pain Therapeutics (PTIE), reported that it has resubmitted the New Drug Application (NDA) for REMOXY® ER to the U.S. Food and Drug Administration (FDA). REMOXY ER is designed as an abuse-deterrent, extended release, capsule formulation of oxycodone, a prescription drug for severe pain. Pain Therapeutics stated that it expects a six-month review cycle by FDA, and that it expects to be notified by FDA of a Prescription Drug User Fee Act (PDUFA) date within 60 days.
Proteostasis Therapeutics, Inc. (NASDAQ: PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF) and other diseases caused by dysfunctional protein processing, this week announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for PTI-428, the Company's cystic fibrosis transmembrane conductance regulator (CFTR) amplifier drug candidate. "This is the second important regulatory designation PTI-428 has been granted from the FDA this week, highlighting our amplifier's potential to provide clinical benefit in the treatment of CF," said Meenu Chhabra, president and chief executive officer of Proteostasis Therapeutics."
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