Saturday, 30 May 2020

Biotechnology and Substance Abuse Markets Have Positive Projections

NEW YORK: According to data published by 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 are important drives for the future of the biotechnology industry.

A major segment of the biotech industry is substance abuse treatment. According to Transparency Market Research, U.S. substance abuse treatment market was value at US$4.42 billion in 2015, and is expected to research US$12.43 Billion by 2024. BioCorRx Inc. (OTC: BICX), Egalet Corporation (NASDAQ: EGLT), Regulus Therapeutics Inc. (NASDAQ: RGLS), DURECT Corporation (NASDAQ: DRRX), Titan Pharmaceuticals, Inc. (NASDAQ: TTNP)

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."

(PRN | 2 years ago)