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`FDA NEWS RELEASE
`FDA approves (cid:161)rst generic naloxone nasal spray to treat opioid
`overdose
`Agency is also taking new steps to support development of over-the-counter and additional generics of
`naloxone to help reduce opioid overdose deaths, increase access to emergency treatment
`
`For Immediate Release:
`April 19, 2019
`
`The U.S. Food and Drug Administration today granted final approval of the first generic naloxone
`hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse
`the effects of an opioid overdose. The agency is also planning new steps to prioritize the review of
`additional generic drug applications for products intended to treat opioid overdose, along with the
`previously announced action to help facilitate an over-the-counter naloxone product (/news-events/press-
`announcements/statement-fda-commissioner-scott-gottlieb-md-unprecedented-new-efforts-support-
`development-over).
`
`“In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose
`reversal treatment more readily available and more accessible. In addition to this approval of the first
`generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for
`naloxone. The FDA has also taken the unprecedented step of helping to assist manufacturers to pursue
`approval of an over-the-counter naloxone product and is exploring other ways to increase the availability of
`naloxone products intended for use in the community, including whether naloxone should be co-
`prescribed with all or some opioid prescriptions to reduce the risk of overdose death,” said Douglas
`Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug
`Evaluation and Research. “All together, these efforts have the potential to put a vital tool for combatting
`opioid overdose in the hands of those who need it most – friends and families of opioid users, as well as
`first responders and community-based organizations. We’re taking many steps to improve availability of
`naloxone products, and we’re committed to working with other federal, state and local officials as well as
`health care providers, patients and communities across the country to combat the staggering human and
`economic toll created by opioid abuse and addiction.”
`
`Today’s approval is the first generic naloxone nasal spray for use in a community setting by individuals
`without medical training; however, generic injectable naloxone products have been available for years for
`use in a health care setting. The FDA also has previously approved a brand-name naloxone nasal spray and
`an auto-injector for use by those without medical training. While business and other considerations may
`impact how quickly this product becomes available, today’s approval is an important step for the agency as
`it works toward expanding access to this live-saving drug. The FDA also held a two-day advisory committee
`
`Opiant Exhibit 2009
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 1
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`(/advisory-committees/advisory-committee-calendar/december-17-18-2018-joint-meeting-anesthetic-
`and-analgesic-drug-products-advisory-committee-and-drug) meeting in December to solicit input and
`advice on strategies to increase the availability of naloxone products intended for use in the community.
`
`According to the Centers for Disease Control and Prevention
`(https://www.cdc.gov/drugoverdose/epidemic/index.html), almost 400,000 people died from an opioid
`overdose from 1999 to 2017, and on average, more than 130 Americans die every day from overdoses
`involving opioids, a class of drugs that include prescription medications such as fentanyl, oxycodone,
`hydrocodone and morphine, as well as illegal drugs such as heroin or drugs sold as heroin. Drugs like
`heroin often contain fentanyl or derivatives of fentanyl. When someone overdoses on an opioid, it can be
`difficult to revive the person to full consciousness, and breathing may become shallow or stop completely –
`leading to death without medical intervention. If naloxone nasal spray (/drugs/postmarket-drug-safety-
`information-patients-and-providers/information-about-naloxone) is administered quickly, it can counter
`the overdose effects, usually within minutes. However, it is important to note that it is not a substitute for
`immediate medical care, and the person administering naloxone nasal spray should seek further
`immediate medical attention on the patient’s behalf.
`
`As part of the U.S. Department of Health and Human Services’ ongoing efforts to combat the opioid crisis
`and expand the use of naloxone, in April 2017, the Department announced its 5-Point Strategy
`(https://www.hhs.gov/opioids/) to Combat the Opioids Crisis. Those efforts include: better addiction
`prevention, treatment, and recovery services; better data; better pain management; better targeting of
`overdose reversing drugs; and better research. In April 2018, Surgeon General VADM Jerome Adams
`issued an advisory (https://www.surgeongeneral.gov/priorities/opioid-overdose-prevention/naloxone-
`advisory.html) (https://www.surgeongeneral.gov/priorities/opioid-overdose-prevention/naloxone-
`advisory.html)encouraging more individuals, including family, friends and those who are personally at risk
`for an opioid overdose to carry naloxone. In December 2018, ADM Brett P. Giroir, M.D., Assistant
`Secretary for Health and the Secretary’s Senior Advisor for Opioid Policy, released guidance
`(https://www.hhs.gov/opioids/sites/default/files/2018-12/naloxone-coprescribing-guidance.pdf)
`(https://www.hhs.gov/opioids/sites/default/files/2018-12/naloxone-coprescribing-guidance.pdf)for
`health care providers and patients detailing how naloxone can help save lives.
`
`One of the ways the FDA is working to increase access to this life-saving treatment is through the approval
`of generic naloxone products. As part of HHS’ public health emergency to address the ongoing opioid
`crisis, the FDA will grant priority review to all abbreviated new drug applications for products indicated for
`the emergency treatment of known or suspected opioid overdose. As part of the priority review, sponsors
`will receive shorter goal dates or standard goal dates with earlier reviewer deadlines; enhanced agency
`communication with sponsors; and expanded agency engagement similar to Generic Drug User Fee Act
`enhancements for complex products, such as pre-submission and midcycle meetings. The FDA has
`determined that further expanding availability of and access to overdose reversal drugs could help address
`the public health emergency.
`
`More generally, in an effort to promote competition to help reduce drug prices and improve access to safe
`and effective generic medicines for Americans, the agency is taking a number of new steps as part of its
`Drug Competition Action Plan. These steps include important work to improve the efficiency of the generic
`drug approval process and address barriers to generic drug development.
`
`Opiant Exhibit 2009
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 2
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`The FDA also remains focused on several additional priorities to address the opioid crisis, including:
`decreasing exposure to opioids and preventing new addiction; fostering the development of novel pain
`treatment therapies; supporting treatment of those with opioid use disorder; and improving enforcement
`and assessing benefit-risk.
`
`Naloxone nasal spray does not require assembly and delivers a consistent, measured dose when used as
`directed. This product can be used for adults or children and is easily administered by anyone, even those
`without medical training. The drug is sprayed into one nostril while the patient is lying on his or her back
`and can be repeated if necessary.
`
`The use of naloxone nasal spray in patients who are opioid-dependent may result in severe opioid
`withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose,
`sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or
`irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.
`
`The FDA tentatively approved this generic drug product on June 8, 2018. Teva Pharmaceuticals USA Inc.
`has received final FDA approval to market generic naloxone nasal spray.
`
`The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health
`by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other
`biological products for human use, and medical devices. The agency also is responsible for the safety and
`security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic
`radiation, and for regulating tobacco products.
`
`###
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`Inquiries
`Media:
` Lyndsay Meyer (mailto:lyndsay.meyer@fda.hhs.gov)
` 240-402-5345
`
`Consumer:
` 888-INFO-FDA
`
` More Press Announcements (/news-events/newsroom/press-announcements)
`
`Opiant Exhibit 2009
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00690
`Page 3
`
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