The statistics are sobering. In the space of just one generation, the entire face of the United States changed. Over an 18-year span, more than 700,000 people died as the result of a drug overdose, according to data cited by the Centers for Disease Control and Prevention (CDCP). In 2017, nearly 70 percent of the 70,200 deaths from drug overdose involved a legal or illegal opioid.
Several States Report Promising Results
Several states, including New York, Ohio and Pennsylvania, have seen decreases in opioid overdoses. Governor Andrew Cuomo noted that New York State Health Department data indicated that areas outside New York City saw a nearly 16 percent decrease in opioid overdoses between 2017 and 2018. It was the first reduction since 2009.
Initiatives passed by the state’s legislature prompted New York to add 27 recovery centers and nearly 500 treatment beds. It’s also easier for patients to get life-saving medications like buprenorphine and methadone. New York distributed more than 8,500 kits that contain naloxone, a medication that can quickly reverse an overdose and offered 449 trainings on how to properly use the medication.
Valuable Weapons in the Fight Against the Opioid Epidemic
To continue the positive gains achieved so far, there are three key opioid antagonists APIs that work in conjunction with each other. These address the common issues that previously made it difficult to stem the opioid epidemic. These three opioid antagonists APIs include:
Vivitrol® and ReVia are two common brand names of naltrexone, although the ReVia brand name is no longer used in the United States. Used primarily as a component of medication-assisted treatment (MAT) when managing opioid or alcohol dependence, naltrexone shouldn’t be started in patients until they have successfully undergone detoxification.
Naltrexone is available orally or via an intramuscular injection. Its effects begin about 30 minutes after administration. For those patients who are dependent on opioids, however, it could take a few weeks for them to experience a reduction in the desire for the drug.
Narcan® is the brand name of naloxone. The medication blocks opioid’s effects on the body and is often used to combat decreased breathing in those patients who are experiencing an opioid overdose. It starts to work within five minutes after being injected into a muscle. When administered intravenously, it starts working within two minutes. A nasal spray is also available.
Most opioids have a duration of action that is greater than naloxone. For that reason, some patients might require more than one dose of the medication. When combined with an opioid in the same pill, naloxone can reduce the risk of misuse associated with opioids.
Similar in both activity and structure to naltrexone, nalmefene — its brand name is Selincro™ — is also an opioid antagonist. Compared to naltrexone, nalmefene has not been observed to cause dose-dependent liver toxicity, it has a longer half-life and it boasts greater oral bioavailability.
An opiate derivative, nalmefene has not yet been approved by the FDA. Though it is currently used primarily to manage alcohol dependence, there are studies underway that are focusing on getting the medication to those who are overdosing as quickly as possible.
Developed as a generic product, the nalmefene HCI injection is being used in the first phase of the study. It will compare the different pharmacokinetic profiles of healthy adults after the administration of various doses of the medication, both intravenously and intramuscularly.
Nalmefene can cause severe withdrawal symptoms in some patients who are opioid-dependent. It can reverse opioid overdose when administered intravenously. As of this writing, nalmefene injections are no longer available. However, oral tablets might be prescribed on an as-needed basis.
Accessible Medications Address the Need
Combating the opioid crisis can be expensive with states having to compete with each other for federal funds. Opting for accessible medications provides the same benefits with a significant reduction in cost. As a result, more lives can be saved from overdosing at a lower cost.
Most recently, FDA joined the fight against the opioid crisis and announced its intention to prioritize review of ANDAs for drug products indicated the emergency treatment of known or suspected opioid overdose. Applications granted priority review can benefit from shorter review times or expedited review without formal reduction of the goal date.
About LGM Pharma
LGM Pharma is a customer-focused innovative organization creating enhanced value by establishing partnerships supporting API needs from R&D through commercialization, providing integrated supply chain solutions for the global pharmaceutical markets. LGM Pharma is recognized as the leading provider of APIs and has GMP sources for all three of the APIs (Naloxone, Naltrexone and Nalmefene). We have been working with clients for years on ANDA and 505(b)(2) projects. At present, we are working on well over 150 API projects using the 505(b)(2) pathway.
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