NEW YORK, February 20, 2018 /PRNewswire/ --
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."
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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Please Note: FinancialBuzz.com is not a financial advisory or advisor, investment advisor or broker-dealer and do not undertake any activities that would require such registration. The information provided on http://www.FinancialBuzz.com (the 'Site') is either original financial news or paid advertisements provided [exclusively] by our affiliates (sponsored content), FinancialBuzz.com, a financial news media and marketing firm enters into media buys or service agreements with the companies which are the subject to the articles posted on the Site or other editorials for advertising such companies. We are not an independent news media provider and therefore do not represent or warrant that the information posted on the Site is accurate, unbiased or complete. FinancialBuzz.com receives fees for producing and presenting high quality and sophisticated content on FinancialBuzz.com along with other financial news PR media services. FinancialBuzz.com does not offer any personal opinions, recommendations or bias commentary as we purely incorporate public market information along with financial and corporate news. FinancialBuzz.com only aggregates or regurgitates financial or corporate news through our unique financial newswire and media platform. FinancialBuzz.com has not been compensated by any companies mentioned. Our fees may be either a flat cash sum or negotiated number of securities of the companies featured on this editorial or site, or a combination thereof. The securities are commonly paid in segments, of which a portion is received upon engagement and the balance is paid on or near the conclusion of the engagement. FinancialBuzz.com will always disclose any compensation in securities or cash payments for financial news dissemination and PR advertising. FinancialBuzz.com does not undertake to update any of the information on the editorial or Site or continue to post information about any companies the information contained herein is not intended to be used as the basis for investment decisions and should not be considered as investment advice or a recommendation. The information contained herein is not an offer or solicitation to buy, hold or sell any security. FinancialBuzz.com, members and affiliates are not responsible for any gains or losses that result from the opinions expressed on this editorial or Site, company profiles, quotations or in other materials or presentations that it publishes electronically or in print. Investors accept full responsibility for any and all of their investment decisions based on their own independent research and evaluation of their own investment goals, risk tolerance, and financial condition. FinancialBuzz.com. By accessing this editorial and website and any pages thereof, you agree to be bound by the Terms of Use and Privacy Policy, as may be amended from time to time. None of the content issued by FinancialBuzz.com constitutes a recommendation for any investor to purchase, hold or sell any particular security, pursue a particular investment strategy or that any security is suitable for any investor. This publication is provided by FinancialBuzz.com. Each investor is solely responsible for determining whether a particular security or investment strategy is suitable based on their objectives, other securities holdings, financial situation needs, and tax status. You agree to consult with your investment advisor, tax and legal consultant before making any investment decisions. We make no representations as to the completeness, accuracy or timeless of the material provided. All materials are subject to change without notice. Information is obtained from sources believed to be reliable, but its accuracy and completeness are not guaranteed. For our full disclaimer, disclosure and Terms of Use. Please visit: http://www.financialbuzz.com .
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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)
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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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About FinancialBuzz.com
FinancialBuzz.com, a leading financial news informational web portal designed to provide the latest trends in Market News, Investing News, Personal Finance, Politics, Entertainment, in-depth broadcasts on Stock News, Market Analysis and Company Interviews. A pioneer in the financially driven digital space, video production and integration of social media, FinancialBuzz.com creates 100% unique original content. FinancialBuzz.com also provides financial news PR dissemination, branding, marketing and advertising for third parties for corporate news and original content through our unique media platform that includes Newswire Delivery, Digital Advertising, Social Media Relations, Video Production, Broadcasting, and Financial Publications.
Please Note: FinancialBuzz.com is not a financial advisory or advisor, investment advisor or broker-dealer and do not undertake any activities that would require such registration. The information provided on http://www.FinancialBuzz.com (the 'Site') is either original financial news or paid advertisements provided [exclusively] by our affiliates (sponsored content), FinancialBuzz.com, a financial news media and marketing firm enters into media buys or service agreements with the companies which are the subject to the articles posted on the Site or other editorials for advertising such companies. We are not an independent news media provider and therefore do not represent or warrant that the information posted on the Site is accurate, unbiased or complete. FinancialBuzz.com receives fees for producing and presenting high quality and sophisticated content on FinancialBuzz.com along with other financial news PR media services. FinancialBuzz.com does not offer any personal opinions, recommendations or bias commentary as we purely incorporate public market information along with financial and corporate news. FinancialBuzz.com only aggregates or regurgitates financial or corporate news through our unique financial newswire and media platform. FinancialBuzz.com has not been compensated by any companies mentioned. Our fees may be either a flat cash sum or negotiated number of securities of the companies featured on this editorial or site, or a combination thereof. The securities are commonly paid in segments, of which a portion is received upon engagement and the balance is paid on or near the conclusion of the engagement. FinancialBuzz.com will always disclose any compensation in securities or cash payments for financial news dissemination and PR advertising. FinancialBuzz.com does not undertake to update any of the information on the editorial or Site or continue to post information about any companies the information contained herein is not intended to be used as the basis for investment decisions and should not be considered as investment advice or a recommendation. The information contained herein is not an offer or solicitation to buy, hold or sell any security. FinancialBuzz.com, members and affiliates are not responsible for any gains or losses that result from the opinions expressed on this editorial or Site, company profiles, quotations or in other materials or presentations that it publishes electronically or in print. Investors accept full responsibility for any and all of their investment decisions based on their own independent research and evaluation of their own investment goals, risk tolerance, and financial condition. FinancialBuzz.com. By accessing this editorial and website and any pages thereof, you agree to be bound by the Terms of Use and Privacy Policy, as may be amended from time to time. None of the content issued by FinancialBuzz.com constitutes a recommendation for any investor to purchase, hold or sell any particular security, pursue a particular investment strategy or that any security is suitable for any investor. This publication is provided by FinancialBuzz.com. Each investor is solely responsible for determining whether a particular security or investment strategy is suitable based on their objectives, other securities holdings, financial situation needs, and tax status. You agree to consult with your investment advisor, tax and legal consultant before making any investment decisions. We make no representations as to the completeness, accuracy or timeless of the material provided. All materials are subject to change without notice. Information is obtained from sources believed to be reliable, but its accuracy and completeness are not guaranteed. For our full disclaimer, disclosure and Terms of Use. Please visit: http://www.financialbuzz.com .
For further information: Media Contact: [email protected] +1-877-601-1879
Url: http://www.FinancialBuzz.com
SOURCE FinancialBuzz.com
