NEW YORK, February 5, 2018 /PRNewswire/ --
According to a reportby BCC research the global substance abuse and addiction treatment market has the potential to reach $4.4 billion annually by 2021. The main reason for the global rise in substance abuse, substance dependence, and addiction
A major portion of the substance abuse market is the opioid abuse segment, which is projected to be valued at $2.5 billion by 2021. Addiction to opioids is on the rise and is leading to serious health problems. BCC Research analyst and report author, Yojana Jeevane, explained, "Drug abuse is a serious health problem affecting peoples' lives and often ruining families… Therefore, it is of prime importance to monitor and control drug abuse, through drug testing that can measure the use of drugs and helps in the evaluation and proper treatment of addiction."
BioCorRx Inc. (OTCQB: BICX) on January 26th the company announced, "that it held a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) on January 24, 2018 regarding the Company's naltrexone implant, BICX102. BICX102 is the Company's sustained release naltrexone implant for the treatment of opioid and alcohol use disorders.
The National Institute on Drug Abuse (NIDA) joined the meeting as observers, along with Brady Granier, CEO and Director of BioCorRx, and the Company's regulatory experts and consultants. In the meeting, BioCorRx discussed the responses that were received prior to the meeting from the FDA in regard to the pre-IND package, which had been submitted last month. The package included information on BICX102, as well as the proposed development plan for commercialization. As a result of the meeting, the Company plans to move forward with the product as anticipated.
Brady Granier, President, CEO and Director of BioCorRx, stated, "We are pleased with the FDA's responses to our development plan and appreciative of their time in the meeting. We look forward to providing a more thorough update as soon as we receive and review the meeting minutes from the FDA as to confirm all items verbally discussed. In the meantime, we will continue moving forward with our BICX102 plans."
Elite Pharmaceuticals, Inc. (OTCQB: ELTP) is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Recently, the company reported positive topline results from a pilot study conducted for SequestOx™, Elite's immediate release Oxycodone Hydrochloride product that incorporates its proprietary abuse-deterrent technology. SequestOx is Elite's investigational abuse-deterrent immediate-release oxycodone product with sequestered naltrexone for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. The study was a Phase 1 pilot, randomized, single-dose, single period, pharmacokinetic study in healthy male and female volunteers in the fed state. The test products included two formulation modifications of SequestOx, a unique abuse-deterrent formulation without sequestered naltrexone, and a reference product. The following table summarizes the Tmax results for the pilot study.
Titan Pharmaceuticals, Inc. (NASDAQ: TTNP), based in South San Francisco, CA, is developing proprietary therapeutics primarily for the treatment of serious medical disorders. The company's lead product is Probuphine®, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. On January 22, 2018, the company confirmed that it and Braeburn Pharmaceuticals, Inc. are in discussions regarding their partnership for the development and commercialization of Probuphine, the first 6-month maintenance treatment of opioid dependence. "We continue to believe that Probuphine has an important role to play in combatting the national epidemic of opioid addiction," said Executive Chairman Marc Rubin, M.D. "To that end, our goal is to make certain that Probuphine is positioned for commercial success, and we will explore all available opportunities to achieve that. We look forward to working with Canaccord Genuity to assist us in this endeavor."
DURECT Corporation (NASDAQ: DRRX) is a biopharmaceutical company actively developing new therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. On December 13, 2017, the company announced that Indivior PLC has reported that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for RBP-7000. RBP-7000 is an investigational, once-monthly injectable risperidone for the treatment of schizophrenia. Indivior PLC further reported that the FDA has set a PDUFA (Prescription Drug User Fee Act) target action date of July 28, 2018. Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy and health policy while providing education on evidence-based treatment models that have revolutionized modern addiction treatment. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence treatments, Indivior has a strong pipeline of product candidates designed to both expand on its heritage in this category and address other chronic conditions and co-occurring disorders of addiction, including alcohol use disorder and schizophrenia.
ImmunoCellular Therapeutics, Ltd. (NYSE: IMUC) is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. On December 13, 2017, the company announced that it has achieved a key milestone in its research-stage Stem-to-T-Cell immuno-oncology program. The milestone represents an important step toward stimulating the patient's immune system to produce an unlimited supply of killer T cells that specifically target and destroy tumor cells with minimal side effects. This approach could be effective in treating many types of cancers. The research team at ImmunoCellular successfully packaged a T cell receptor (TCR) DNA sequence into a lentiviral vector, which was then used to transfect human hematopoietic stem cells. The Company has been able to verify successful transfer of genetic material into the stem cells, and plans to continue to work toward optimizing the transfection process. The Company believes that this completed phase of the Stem-to-T-Cell development is an important component of the proof-of-concept work for this technology, and represents a critical step in advancing toward preclinical testing.
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