On Wednesday, Teva Pharmaceuticals announced the launch of a first-to-market generic version of Narcan (naloxone hydrochloride nasal spray), in the United States.
Teva has one of the largest portfolios of FDA-approved generic drugs on the U.S. market. It holds the leading position in first-to-file opportunities. Currently, at least one in 12 generic drugs dispensed in the U.S. is a Teva product.
Naloxone nasal spray is an FDA-approved treatment for known or suspected opioid overdose. It is needle-free and ready to use. It is a prescription medicine for an opioid emergency or a possible opioid overdose with symptoms of breathlessness, severe sleepiness or not being able to respond.
Narcan Nasal Spray may counteract the life-threatening effects of an opioid overdose. Most accidental drug overdoses occur in a home setting so the product was developed for first responders, such as family, friends, and caregivers, who have no medical training.
Narcan Nasal Spray is designed for ease of use in the community setting. It does not require inhalation and specialized training.
It is important to get emergency medical assistance right away after giving the first dose of Generic Narcan Nasal Spray. One can perform rescue breathing or CPR (cardiopulmonary resuscitation) until emergency medical help arrives.
Remember that the signs and symptoms of an opioid overdose could return after the nasal spray is given. And if this happens, one can give another dose after a couple of minutes using a new Narcan Nasal Spray and watch the person closely until emergency help is received.
Like all synthetic drugs, Generic Narcan Nasal Spray may cause serious side effects, including sudden opioid withdrawal symptoms.
For people who have been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving Generic Narcan Nasal Spray. They may experience body aches, diarrhea, increased heart rate, palpitation, runny nose, sneezing, sweating, nausea or vomiting, nervousness, restlessness or irritability, weakness, or increased blood pressure.
In April 2019, the U.S. Food and Drug Administration (FDA) granted final approval of the first generic naloxone hydrochloride nasal spray.
At the time, Dr. Douglas Throckmorton, Deputy Center Director for Regulatory Programs in the FDA’s Center for Drug Evaluation and Research, said, “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,” he added. “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.”