Tag Archives: buprenorphine

Generic Medications for Opioid Dependence

FDA Approves Two Generic Medications for Opioid Dependence Treatment

FDA Approves Two Generic Medications for Opioid Dependence Treatment

Mylan Technologies Inc. and Dr. Reddy’s Laboratories SA have received the go-ahead to market buprenorphine and naloxone sublingual film. These products will be made available to patients as generic versions of Suboxone, a medication used to treat opioid dependence.

Buprenorphine is used to reduce the severity of opioid withdrawal symptoms. Naloxone blocks their effects and reverses the same. The two medications can be used as part of an overall treatment program that includes counseling and prescription monitoring.

More Help Available for Opiate Addiction

Generic buprenorphine and naloxone sublingual film will be available in several dosage levels. These medications can only be prescribed by medical professionals certified by the Drug Addiction Treatment Act.

Dr. Scott Gottlieb, the FDA Commissioner, stated that the FDA is taking steps to “advance the development of improved treatments for opioid use disorder” and to ensure that these medications are available to patients who need them. He also said that includes “promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access.”

About Medication-Assisted Treatment

Medication-assisted Treatment (MAT) is a treatment option that uses FDA-approved medications (buprenorphine, methadone or naltrexone) along with counseling and other types of behavioral therapies, to treat opioid addiction. This form of treatment reduces the severity of withdrawal symptoms. The medications used for MAT don’t give participants the “high” or feeling of ecstasy normally associated with opioid abuse, although some of these medications can wind up being abused as well, so they alone are not a permanent solution.

At an appropriate therapeutic dose for a patient, buprenorphine is also supposed to reduce the pleasurable effects he would experience if he took other opioids. This effect would make continued use of opioids less attractive, therefore much less likely.

Patients who are receiving MAT for opioid use disorder benefit from this type of treatment in another way as well: they cut their risk of dying by 50 percent, according to the Substance Abuse and Mental Health Services Administration (SAMHSA).

Med Conference: Buprenorphine Effective for Addiction Treatment

Attendees at a presentation during Hospital Medicine 2018 learned that the drug buprenorphine is appropriate to prescribe for hospitalized patients with opioid use disorders. The same medication is also effective for treating the acute pain experienced by patients being treated using buprenorphine.

Significant Increase in Drug Overdose Deaths

Dr. Anika Alvanzo, from John Hopkins Medicine, made a presentation at the conference. She referred to the significant increase in drug overdose deaths over the past 20 years. The number of fatalities jumped from three percent per year between 2006-2014 and 18 percent per year in the years 2014-2016. Dr. Alvanzo said that a large number of these deaths can be linked to increased use of synthetic opioids.

Types of Prescription Pain Medications

While some people refer to opioids to describe all types of prescription pain medications, they differ in the way they are made.

• Opiates are natural pain medications that are derived from opium. The opium is extracted from the opium poppy and is used to make medications such as morphine and codeine.
• Synthetic opioids are manufactured by humans and include methadone and fentanyl.
• Semi-synthetic opioids are a hybrid made from making chemical modifications to opiates. Drugs in this category include oxycodone, hydromorphone and buprenorphine.

Buprenorphine Availability a Bridge to Treatment for Opioid Use Disorders

Dr. Alvanzo stated during her presentation that there are currently three medications approved by the Food and Drug Administration (FDA) for treating opioid use disorder: buprenorphine, naltrexone and methadone. She went on to say that when buprenorphine is prescribed to patients on discharge from hospital, it “significantly increases” the likelihood that the patient will seek professional treatment. Approximately 75 percent of patients were in treatment one month after discharge.

The doctor urged her colleagues attending Hospital Medicine 2018 to consider getting their buprenorphine certification so that they can order the drug within the hospital and at discharge for patients. She referred to buprenorphine availability as a “bridge to treatment” for opioid use disorders patients.

Buprenorphine for Addiction Treatment

States Expanding Access to Buprenorphine for Addiction Treatment

Buprenorphine for Addiction TreatmentThere continues to be a high demand for medication-assisted treatment (MAT) for opioid addiction. To date, however, states like Ohio only haveabout two percent of doctors that have completed the training necessary to prescribe or dispense buprenorphine. This is the main ingredient in the addiction treatment drug Suboxone, and other similar medications.

Plan to Double Healthcare Professionals Providing Buprenorphine

The state is planning to double the number of healthcare professionals certified to provide Suboxone (and other addiction treatment medications) to patients over the next 18 months. The federal government has provided $26 million in grant funding under the 21st Century Cares Act so that more healthcare providers can get training. Under existing law, doctors, as well as nurse practitioners and physician assistants (PAs) can dispense buprenorphine.

Waiver to Treat Patients for Opioid Addiction

Under the Drug Addiction Treatment Act of 2000 (Data 2000), doctors can apply for a waiver allowing them to treat patients with buprenorphine in their office, clinic, a community hospital or “any other setting where they are qualified to practice.” To qualify for a physician waiver, a doctor must be:

• Licensed under state law
• Registered with the DEA (Drug Enforcement Administration) to dispense controlled substances
• Agree to treat a maximum of 30 MAT patients during the first year
• Qualify to treat MAT patients, either by training or by professional certification

A doctor who has completed at least eight hours of classroom training focused on treating and managing patients with opioid use disorders can qualify for a waiver. The new training program for medical professionals is 1.5 days of classroom instruction, and participants are expected to continue their education through online courses and seminars.

Medication-Assisted Treatment Growing in the United States

The National Institutes of Health Studies says that MAT is a very effective method for treating opioid addiction. Studies conducted in 2014 revealed improved long-term recovery rates over traditional treatment methods, though it often takes finding the perfect balance for each individual as to how long they stay on the medication. Ideally, they would work toward being off of it in 2 years or less, and many people seek to use Suboxone for short-term tapering to simply ease opiate withdrawal symptoms.

injection treatment for opioid addiction

Monthly Injection Treatment for Opioid Addiction Approved by FDA

The FDA (US Food and Drug Administration) has approved a monthly treatment for addiction that is the first of its kind. The new option can be used for those struggling with substance abuse issues stemming from an addiction to narcotics such as prescription painkillers or heroin.

Sublocade, from Indivior Plc, is buprenorphine given by injection. The drug reduces the sensations of withdrawal symptoms in addiction patients. Administering the drug monthly could help patients comply to the treatment schedule, compared to other versions currently available such as daily oral doses in the form of pills or dissolving strips.

Effort to Reduce Stigmas Around Drugs

Approving the new drug treatment product is part of the Administration’s plan to reduce stigmas surrounding this class of medications. Buprenorphine is a synthetic opioid, and critics have expressed their opposition to medication assisted treatment (MAT). Instead, they favor changing users’ behavior to combat the current opioid crisis.

The FDA and other federal agencies are supporting MAT, which involves administering drugs and providing counseling to those affected. The White House referred to the situation as a “public health emergency” in October.

The FDA commissioner, Scott Gottlieb, released a statement recently that said the FDA is “committed to expanding access to treatments that can help people pursue lives of sobriety.”

New Medication Available Early in 2018

According to reports, Sublocade will be made available to patients early in 2018, according to Indivior. The National Institute on Drug Abuse reports that in 2016, drug overdoses were responsible for taking the lives of more than 64,000 Americans. This figure includes overdoses caused by prescription drugs, such as fentanyl and OxyContin, and illicit ones like heroin. Clients who receive medication assisted treatment for drug addiction reduce their risk of death from all causes in half, according to the FDA, making this option a valuable one.

Mr Gottlieb stated that the FDA is currently working on guidelines that will get further treatment options for treating opioid addiction into the market more rapidly.

Many Patients Receiving Treatment for Opioid Addictions Still Being Prescribed Painkillers

Opioid AddictionsA new study conducted by researchers at Johns Hopkins Bloomberg School of Public Health revealed a major problem with prescribing practices in several states throughout the country. It was discovered that many patients who were receiving prescriptions for buprenorphine to treat their opioid addictions were also receiving prescriptions for prescription painkillers at the same time.

According to information from eleven states, two in five patients that were using buprenorphine were also being prescribed prescription painkillers. Additionally, it was discovered that 66% of people who had completed treatment were also being prescribed painkillers within 12 months.

This shocking discovery only serves to highlight the obvious need for better prescribing practices, prescription drug monitoring programs and more education for doctors. “Policymakers may believe that people treated for opioid addiction are cured, but people with substance abuse disorders have a lifelong vulnerability, even if they are not actively using. Our findings highlight the importance of stable, ongoing care for these patients,” commented Dr. G. Caleb Alexander, study author.

Many experts agree with Dr. Alexander. Treatment has been found to be one of the most effective ways to overcome an addiction to opiates. However, many people struggle to find a treatment facility that is right for them. This is made even more difficult by the potential changes being implemented surrounding the Affordable Care Act, which helped increase access to treatment for more people.

There are many successful ways of treating opioid addiction, and using burprenorphine (Suboxone) as an aid to reduce withdrawal symptoms and cravings has proven to have multiple benefits. What this study shows is that the healthcare system in America has a long way to go to help fix the opioid crisis that appears to be continuing to escalate.

U.S. Dept. of Health Continues Fight Against Opioid Addiction

painkillersThe United States Department of Health and Human Services (HHS) announced earlier this month new efforts to make an impact on the opioid problem in America. There were three main areas of focus included in this announcement, which were improving prescribing practices, increasing access to medication-assisted treatment and making naloxone more widely available for emergencies.

With this came what many consider the big news that doctors who are approved to prescribe buprenorphine have been able to more than double the number of people they can treat at a time. They were previously limited to 100 patients, but the Substance Abuse and Mental Health Services Administration (SAMHSA) just raised that cap to 275 patients.

Secretary of Health and Human Services Sylvia Burwell stated, “The opioid epidemic is one of the most pressing public health issues in the United States. More Americans now die from drug overdoses than car crashes, and these overdoses have hit families from every walk of life and across our entire nation. At HHS, we are helping to lead the nationwide effort to address the opioid epidemic by taking a targeted approach focused on prevention, treatment, and intervention.”

The part that seems to stand out as having the greatest overall impact is the changing of prescribing practices by doctors who give out painkillers. Opiates have been too heavily relied on to treat various pain conditions, while at the same time underestimating their abuse and addiction potential, and a major overhaul is sorely needed.

In the meantime, wider availability and use of medications that like naloxone and buprenorphine can help to reduce the damage caused by painkillers and other opiates so that there is a better chance at rehabilitation. Most people want, and deserve, long-term fixes for opioid problems rather than temporary patches.

If you or someone you love has a problem with painkillers, heroin or any other type of drug, contact Desert Cove Recovery today to see how we can help.

Doctors Issue New Guidelines for Treating Opioid Addiction

doctors studyingThe medical community is immersed in the prescription painkiller epidemic in two ways. On the front end, doctors are often the ones prescribing the drugs like Oxycontin, Percocet and Vicodin to patients. Medical professionals are essentially the gatekeepers of prescription painkillers and often have to decide if patients are in legitimate need of medication or if they are seeking the painkillers to feed their addictions.

Additionally, doctors are also charged with treating addicts who are seeking help for their substance abuse problems. Because of this two-fold interaction with the prescription painkiller problem, the American Society of Addiction Medicine (ASAM) gathered doctors from around the country to develop better policies for dealing with the painkiller epidemic.

The first problem that the group encountered was the insufficient training in addiction medicine for most doctors. While most physicians certainly understand the basic fundamentals of addiction, the nuances of treating this disease is considered a specialized form of medicine.

Doctors who are not familiar with addiction treatments often do not prescribe medication designed to help with drug withdrawals and detox, such as buprenorphine. While studies show that monitored use of drug replacement medications illicit better results in treatment, many doctors still consider this is replacing one dependency for another when used indefinitely. Suboxone is one of the most popular medications given to patients with a heroin or prescription painkiller addiction, ad currently only doctors who meet certain criteria are allowed to prescribe the medication.

Another problem that was discussed during the meeting was the lack of treatment facilities. Currently, state-run facilities oftentimes run at capacity, while private treatment centers are struggling to keep up with the demand. Doctors can contribute to the treatment problem by encouraging addicts to seek treatment, helping them locate appropriate treatment and staying up to date with the changing methods of treating addicts.

“We just don’t have enough specialty treatment facilities and expertise in this country to treat everyone. That’s why we need guidelines like this as part of a larger movement to help integrate treatment into general practice,” explained Christopher Jones from the Department of Health and Human Services.

These new guidelines are scheduled to be included in the new ASAM’s National Practice Guideline and will also be included in the CDC’s Guideline for Prescribing Opioids for Chronic Pain coming out in the near future.