NOVARTIS AG Approximately every 8 minutes in the US a life is lost to an opioid overdose.4 Opioid dependency and accidental opioid overdoses are a serious national crisis affecting public health and social and economic welfare. Opioid overdose death rates have been continuously increasing in the US for over two decades.5
During the COVID-19 pandemic, increased stressors such as isolation, unemployment and illness-along with disruptions in health care and obstacles obtaining treatment-have put people at increased risk of opioid overdose.6 Of the 49 million patients prescribed opioids in the US, more than 18 million are considered at-risk, but only five percent received a prescription for naloxone.7
'Now more than ever, it's imperative that Americans have increased access to life-saving opioid overdose reversal medicines for themselves or a loved one,' said
In
All 50 states in the US allow for access to the 4 mg naloxone hydrochloride nasal spray either directly from a pharmacist without a prescription under a Statewide Standing Order, a Collaborative Practice Agreement between pharmacists and other health care providers or through a third-party prescription that allows someone other than the patient to obtain the 4 mg naloxone hydrochloride nasal spray to assist an at risk individual.10 Family and friends are often in the best position to administer this potentially lifesaving drug to those who overdose. State laws vary for eligibility and distribution.11
To learn more about the
Narcan is a registered trademark of
INDICATION AND USAGE
Naloxone HCl Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. Naloxone HCl Nasal Spray is not a substitute for emergency medical care.
IMPORTANT SAFETY INFORMATION
Naloxone HCl Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.
Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.
Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.
Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.
Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal characterized by body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose. Monitor for the development of opioid withdrawal.
In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may also include convulsions, excessive crying, and hyperactive reflexes.
Abrupt Postoperative Reversal of Opioid Depression: Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest. Serious sequelae of these events, including coma and death, have been reported. These events have primarily occurred in patients who had pre-existing cardiovascular (CV) disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone HCl.
Adverse Reactions: The following adverse reactions were observed in a Naloxone HCl Nasal Spray clinical study: increased blood pressure, constipation, toothache, muscle spasms, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma.
Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as 'potential,' 'can,' 'will,' 'plan,' 'may,' 'could,' 'would,' 'expect,' 'anticipate,' 'look forward,' 'believe,' 'committed,' 'investigational,' 'pipeline,' 'launch,' or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product's label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit
About
CEO
References
1.
2.
3. Naloxone hydrochloride nasal spray. Prescribing information. Available at: https://sandoz-naloxone.com/pdf/naloxone-pi.pdf. Accessed
4.
5.
6.
7. Data extracted from IQVIA Pharmacy Claims Database in the retail and mail channels for the 12 months of
8.
9.
10.
11.
Contact:
Novartis Media
E-mail: media.relations@novartis.com
M: +1 862 579 8456
E: julie.masow@novartis.com
M: +1 201 354 0279
E: leslie.pott@sandoz.com
Novartis Investor
Central Investor Relations
T: +41 61 324 7944
E-mail: investor.relations@novartis.com
T: +1 862 778 5052
(C) 2021 Electronic News Publishing, source
