NEW YORK, February 20, 2018 /PRNewswire/ --
According to data publishedby Grand View Research, Inc. the global biotechnology market is projected to reach a value of USD 727.1 billion by 2025. Major technological developments in segments such as regenerative medicine, genetics and diagnostics
Opioids are the most widely prescribed medications or the treatment of chronic pain conditions. Opioids are also a major cause of drug overdoses and substance abuse. The New York Times reported data provided by the CDC, according to which Drug overdoses killed roughly 64,000 people in the United States in 2016. A very strong increase of more than 22 percent from the previous year. Deekshita Allavarapu, Analyst for GBI Research, explains: "The FDA has raised concerns over the high use, and the potential for misuse, of opioids. This could lead to the enforcement of regulatory checks that affect the opioid treatment market and its potential growth."
BioCorRx Inc. (OTCQB: BICX) last week the company announced, "Results of its pre-Investigational New Drug (pre-IND) meeting with the United States Food & Drug Administration (FDA). The FDA has deemed the 505(b) (2) pathway as an acceptable route for approval for BICX102, a sustained release naltrexone implant for the treatment of opioid and alcohol use disorders. The 505(b) (2) pathway is intended to provide an abbreviated route to approval with less study requirements than traditional applications. Based on the FDA's guidance, no additional efficacy studies are being considered. In addition, the Company announced that based on the FDA's responses, it plans to apply for dual indications, both opioid use disorder and alcohol use disorder, within the same application. A nonclinical safety study and a clinical pharmacokinetic (PK) study will be conducted as the Company expected and planned for prior to the pre-IND meeting. Clinical safety and human factor testing will also be performed as suggested by the FDA."
Brady Granier, President, CEO and Director, stated, "We are excited with the responses we have received on our development plan from the FDA. With the FDA agreeing that the 505(b) (2) pathway is acceptable for BICX102, this means that we should be able to help more people, sooner than traditional routes of approval. We expect to have relatively lower costs and a faster path to approval with this abbreviated route. Also, the ability to seek approval on two indications at the same time using the same studies would be an enormous time and cost savings to the Company. The opioid epidemic gets all the headlines for the right reasons, but alcohol use disorder is a continuous, massive problem that we have never neglected. We are particularly grateful for the support we have received from both the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Preparation for certain National Institutes of Health (NIH) grant applications are underway now that we have enough information from the FDA to proceed. The submission period for these grants has just started. We also plan to file our IND application soon and hope to have updates available as things progress."
Egalet Corporation (NASDAQ: EGLT), a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions. On January 23, 2018, the company announced that its partner OraPharma, a division of Valeant Pharmaceuticals International, Inc., has begun promoting SPRIX® (ketorolac tromethamine) Nasal Spray to more than 9,000 dentists and oral surgeons across the United States. Under the agreement announced earlier this month, the OraPharma sales team will promote SPRIX Nasal Spray along with their own portfolio of products to their target dentists and oral surgeons. SPRIX Nasal Spray is a nonsteroidal anti-inflammatory drug (NSAID) indicated in adults for short-term (up to five days) management of moderate to moderately severe pain that requires analgesia at the opioid level.
Regulus Therapeutics Inc. (NASDAQ: RGLS) is a clinical stage biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. On December 19, 2017, the company announced that it has initiated the first-in-human Phase I study of RGLS4326 and completed dosing of the first cohort of healthy volunteers. RGLS4326 is in development for the treatment of autosomal dominant polycystic kidney disease, or ADPKD. RGLS4326 is being studied in a Phase I randomized, double-blind, placebo-controlled, single ascending dose study designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RGLS4326 administered subcutaneously in healthy volunteers.
DURECT Corporation (NASDAQ: DRRX) is a biopharmaceutical company developing therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. Recently, the company announced that its licensee, Pain Therapeutics, 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. REMOXY ER, an investigational drug, is a unique long-acting oral formulation of oxycodone intended to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Based on DURECT's ORADUR® technology, which is covered by issued patents and pending patent applications owned by us, REMOXY ER is designed to discourage common methods of tampering associated with prescription opioid analgesic misuse and abuse.
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.
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