February 13, 2015 I Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride), extended-release capsules, an abuse-deterrent formulation (ADF) opioid for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. ALO-02 is an extended-release oxycodone specifically designed to reduce abuse via the oral, intranasal (i.e., snorting) and intravenous (IV) routes when crushed.
Prescription opioids are an important treatment option for patients with chronic pain, but the misuse, abuse, and diversion of these agents remains a serious and persistent problem. In 2013, according to the National Survey on Drug Use and Health, nearly 10 million U.S. adults reported prescription pain reliever use for non-medical purposes in the previous year1. Abuse deterrent opioid medications incorporate technology designed to make the product difficult to abuse, yet when used appropriately, provide patients with intended pain relief. Pfizer believes that abuse deterrent formulation opioids, including ALO-02, are an important step toward helping to address the growing public health issue of opioid abuse in the U.S. Pfizer supports the appropriate use of opioid pain medications and is committed to research in this field. If approved, ALO-02 would become Pfizer’s second abuse deterrent formulation opioid.
Pfizer’s submission to the FDA is based on the results of two Phase 3 trials in patients with moderate-to-severe, non-cancer chronic pain. In addition, Pfizer conducted three abuse-potential studies in recreational opioid users, comparing the abuse potential of crushed ALO-02 with immediate-release oxycodone when taken by the oral, intranasal or intravenous (the combination of oxycodone and 12% naltrexone was used to simulate crushed ALO-02 in the IV study) routes.
About ALO-02
ALO-02 capsules contain pellets that consist of extended-release oxycodone hydrochloride, an opioid agonist, which surround sequestered naltrexone hydrochloride, an opioid receptor antagonist. When used as directed, the naltrexone remains sequestered and patients receive oxycodone in an extended release manner. When the pellets are crushed in an attempt to misuse or abuse ALO-02, naltrexone is released and is designed to counteract the effects of oxycodone.
Pfizer Inc.: Working together for a healthier world
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.
1 Substance Abuse and Mental Health Services Administration, Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-48, HHS Publication No. (SMA) 14-4863. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2014.
SOURCE: Pfizer
Post Views: 480
February 13, 2015 I Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride), extended-release capsules, an abuse-deterrent formulation (ADF) opioid for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. ALO-02 is an extended-release oxycodone specifically designed to reduce abuse via the oral, intranasal (i.e., snorting) and intravenous (IV) routes when crushed.
Prescription opioids are an important treatment option for patients with chronic pain, but the misuse, abuse, and diversion of these agents remains a serious and persistent problem. In 2013, according to the National Survey on Drug Use and Health, nearly 10 million U.S. adults reported prescription pain reliever use for non-medical purposes in the previous year1. Abuse deterrent opioid medications incorporate technology designed to make the product difficult to abuse, yet when used appropriately, provide patients with intended pain relief. Pfizer believes that abuse deterrent formulation opioids, including ALO-02, are an important step toward helping to address the growing public health issue of opioid abuse in the U.S. Pfizer supports the appropriate use of opioid pain medications and is committed to research in this field. If approved, ALO-02 would become Pfizer’s second abuse deterrent formulation opioid.
Pfizer’s submission to the FDA is based on the results of two Phase 3 trials in patients with moderate-to-severe, non-cancer chronic pain. In addition, Pfizer conducted three abuse-potential studies in recreational opioid users, comparing the abuse potential of crushed ALO-02 with immediate-release oxycodone when taken by the oral, intranasal or intravenous (the combination of oxycodone and 12% naltrexone was used to simulate crushed ALO-02 in the IV study) routes.
About ALO-02
ALO-02 capsules contain pellets that consist of extended-release oxycodone hydrochloride, an opioid agonist, which surround sequestered naltrexone hydrochloride, an opioid receptor antagonist. When used as directed, the naltrexone remains sequestered and patients receive oxycodone in an extended release manner. When the pellets are crushed in an attempt to misuse or abuse ALO-02, naltrexone is released and is designed to counteract the effects of oxycodone.
Pfizer Inc.: Working together for a healthier world
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.
1 Substance Abuse and Mental Health Services Administration, Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-48, HHS Publication No. (SMA) 14-4863. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2014.
SOURCE: Pfizer
Post Views: 480
