FDA News

FDA approves generic Narcan nasal spray

The FDA recently approved the first generic nasal spray of the opioid overdose antidote Narcan for use in a community setting without medical training, according to a FDA press release.

“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,” Douglas Throckmorton, MD, deputy center director for regulatory programs at the FDA Center for Drug Evaluation and Research said in the release.

The approval of the generic version of Narcan (naloxone hydrochloride, TevaPharmaceuticals) comes several years after the 2-mg and 4-mg versions manufactured by Adapt Pharma were approved by the FDA. In addition, earlier this year, the agency proactively developed and tested a product label for the first time to encourage development of an over-the-counter version of naloxone.

Robert Freeman
Robert A. Freeman

Robert A. Freeman, PhD, professor in the department of pharmacy practice and administration at the School of Pharmacy and Health Professions at the University of Maryland Eastern Shore, said he had “no concerns” about the drug’s approval.

“Essentially, it’s the same as the brand in terms of efficacy and safety, plus it increases the supply of naloxone. Other generic versions will be available following expiration of the 6-month exclusivity period granted to the first generic to enter the market,” Freeman said in an interview. “This is a positive.”

Gary Kaplan
Gary Kaplan

Although Gary Kaplan, DO, founder of the Kaplan Center for Integrative Medicine, in McClean, Virginia, called the generic drug’s availability an essential step toward helping abate the opioid crisis, but he also said it was only a temporary solution to a problem of such enormous depth.

“This is a band-aid. an important one that will save lives but one that allows drug companies, who in no small part created the problem, to make money off a fix to the problem. Frankly, I am tired of the piecemeal approach where drug companies continue to benefit, and Americans continue to suffer and die,” he told Healio Primary Care Today.

Kaplan added that the solution to the opioid epidemic lies in economics, not pharmaceutics.

Pill Bottles 
The FDA recently approved the first generic nasal spray of the opioid overdose antidote Narcan for use in a community setting without medical training, according to a FDA press release.

Source:Adobe

“We need to locate money to seed private and government solutions to the opioid crisis and target the communities that have been hardest hit first, rural America. These communities are depressed economically with jobs that traditionally cause more injuries, underserved medically with physicians who are often overwhelmed, leading to hardship that devastates families.”

“Too often, those of us in academia and urban practices assume we understand the needs of colleagues practicing in very different environments than our own. If we are going to get serious about solving the opioid crisis in this country, we are going to have to find a way to reinvigorate our rural communities with opportunities for good jobs with a future, the medical resources to help them heal, keep them healthy and give them hope for a better future,” Kaplan continued.

Others agreed with Kaplan on the importance of a generic of naloxone becoming available and how it is not the only step needed to end the epidemic.

Lewis Nelson
Lewis Nelson

“While naloxone likely has an important role in preventing death, and this new generic version will likely help, it does not address the fundamental issues underlying the opioid crisis such as poor opioid prescribing, heroin and illicit synthetic opioids, and limited resources for addiction treatment,” Lewis Nelson, MD, a former chair of FDA’s Drug Safety and Risk Management Advisory Committee, and now a chair in the department of emergency medicine at Rutgers New Jersey Medical School said in an interview.

He said that those who use naloxone should do so cautiously.

“As also noted by FDA, severe withdrawal may occur, and while a better outcome than death, most patients who overdose do not die. This added harm to patients who will not otherwise die changes the risk to benefit balance of administering this antidote. However, since it is difficult for a layperson to determine which patient with an opioid overdose will die, it is not practical to selectively administer naloxone. Therefore, FDA, health care providers, and patient families and advocates generally feel that withdrawal-related risks are worth taking.”

Neither the price of naloxone nor its available date to the public could be determined before this story’s posting. – by Janel Miller

Disclosures: Neither Freeman, Kaplan nor Nelson reported any relevant financial disclosures.

 

The FDA recently approved the first generic nasal spray of the opioid overdose antidote Narcan for use in a community setting without medical training, according to a FDA press release.

“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,” Douglas Throckmorton, MD, deputy center director for regulatory programs at the FDA Center for Drug Evaluation and Research said in the release.

The approval of the generic version of Narcan (naloxone hydrochloride, TevaPharmaceuticals) comes several years after the 2-mg and 4-mg versions manufactured by Adapt Pharma were approved by the FDA. In addition, earlier this year, the agency proactively developed and tested a product label for the first time to encourage development of an over-the-counter version of naloxone.

Robert Freeman
Robert A. Freeman

Robert A. Freeman, PhD, professor in the department of pharmacy practice and administration at the School of Pharmacy and Health Professions at the University of Maryland Eastern Shore, said he had “no concerns” about the drug’s approval.

“Essentially, it’s the same as the brand in terms of efficacy and safety, plus it increases the supply of naloxone. Other generic versions will be available following expiration of the 6-month exclusivity period granted to the first generic to enter the market,” Freeman said in an interview. “This is a positive.”

Gary Kaplan
Gary Kaplan

Although Gary Kaplan, DO, founder of the Kaplan Center for Integrative Medicine, in McClean, Virginia, called the generic drug’s availability an essential step toward helping abate the opioid crisis, but he also said it was only a temporary solution to a problem of such enormous depth.

“This is a band-aid. an important one that will save lives but one that allows drug companies, who in no small part created the problem, to make money off a fix to the problem. Frankly, I am tired of the piecemeal approach where drug companies continue to benefit, and Americans continue to suffer and die,” he told Healio Primary Care Today.

Kaplan added that the solution to the opioid epidemic lies in economics, not pharmaceutics.

Pill Bottles 
The FDA recently approved the first generic nasal spray of the opioid overdose antidote Narcan for use in a community setting without medical training, according to a FDA press release.

Source:Adobe

“We need to locate money to seed private and government solutions to the opioid crisis and target the communities that have been hardest hit first, rural America. These communities are depressed economically with jobs that traditionally cause more injuries, underserved medically with physicians who are often overwhelmed, leading to hardship that devastates families.”

“Too often, those of us in academia and urban practices assume we understand the needs of colleagues practicing in very different environments than our own. If we are going to get serious about solving the opioid crisis in this country, we are going to have to find a way to reinvigorate our rural communities with opportunities for good jobs with a future, the medical resources to help them heal, keep them healthy and give them hope for a better future,” Kaplan continued.

Others agreed with Kaplan on the importance of a generic of naloxone becoming available and how it is not the only step needed to end the epidemic.

Lewis Nelson
Lewis Nelson

“While naloxone likely has an important role in preventing death, and this new generic version will likely help, it does not address the fundamental issues underlying the opioid crisis such as poor opioid prescribing, heroin and illicit synthetic opioids, and limited resources for addiction treatment,” Lewis Nelson, MD, a former chair of FDA’s Drug Safety and Risk Management Advisory Committee, and now a chair in the department of emergency medicine at Rutgers New Jersey Medical School said in an interview.

He said that those who use naloxone should do so cautiously.

“As also noted by FDA, severe withdrawal may occur, and while a better outcome than death, most patients who overdose do not die. This added harm to patients who will not otherwise die changes the risk to benefit balance of administering this antidote. However, since it is difficult for a layperson to determine which patient with an opioid overdose will die, it is not practical to selectively administer naloxone. Therefore, FDA, health care providers, and patient families and advocates generally feel that withdrawal-related risks are worth taking.”

Neither the price of naloxone nor its available date to the public could be determined before this story’s posting. – by Janel Miller

Disclosures: Neither Freeman, Kaplan nor Nelson reported any relevant financial disclosures.

 

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