FDA Designates Opioid Overdose Treatment for Fast Track Development Program

FDA“A Kentucky company headed by a recognized expert in nasal delivery of medication says its intranasal naloxone spray, a drug designed to treat opioid overdoses, has received Fast Track designation from the Food and Drug Administration (FDA).

The Fast Track program of the FDA is designed to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track-designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process. AntiOp and the FDA may also be able to employ additional tools to expedite the FDA review process such as “rolling submission,” whereby AntiOp may submit portions of the new drug application (NDA) in a staged NDA submission process.”

http://www.marketwatch.com/story/fda-designates-opioid-overdose-treatment-for-fast-track-development-program-2014-07-15 

Source: MarketWatch.com – July 15, 2014

 

 

Blog by Jana Burson – Naloxone

“Naloxone is the opioid buzz-kill drug… and it’s also the opioid overdose life saver.

People die from opioid overdoses because the brain gets saturated with opioids. The part of the brain that tells us to breathe during sleep, the medulla, also gets saturated, and eventually shuts off. This usually occurs gradually. The respiratory rate slows over one to three hours, until all respirations stop. Then tissues of essential organs like the brain and heart die from lack of oxygen.

If naloxone can be given during this process, the opioids are tossed off brain receptors, and the medulla fires urgent orders for the body to resume breathing. The patient wakes up, so long as irreversible damage hasn’t yet been done to the brain and heart. In some cases, the patient goes into full precipitated opioid withdrawal, but usually the naloxone doesn’t reverse all of the opioids on board, just enough to save the patient’s life.”

http://janaburson.wordpress.com/2014/06/15/naloxone/

Source: Jana Burson – June 15, 2014

Project Lazarus Brings Opioid Treatment Program to Wilkes County Along With Naloxone Kits

kitProject Lazarus, a nonprofit organization based in Moravian Falls, North Carolina, is best known nationally for its work on making the overdose-reversal medication naloxone more available. But the organization, under the guidance of CEO Fred Wells Brason II, was also instrumental in bringing the first opioid treatment program (OTP) to Wilkes County North Carolina. It started as a buprenorphine clinic, which was more palatable to physicians, and then became a full-service OTP including methadone.

The first time Mr. Brason suggested that the county needed an OTP was in 2006, and the response, he recalled, was virulently anti-methadone. “They said, ‘not in our county, and not a drug for a drug.’” But there was no treatment available for people with opioid addiction.

But Mr. Brason, a combination of optimism, determination, and diplomacy, worked out an agreement. First, he got Mountain Health Solutions, an Asheville-based OTP, now owned by CRC Health Group, to set up a satellite clinic in Wilkes County. They would provide only buprenorphine at first—something that was more acceptable by the town. “At least we had something,” he said. Then, he embarked on a two-year education program focusing on methadone. “We talked about addiction, about treatment, and did a lot of myth-busting,” he said. In addition, census in the buprenorphine clinic continued to grow—and Mr. Brason knew that patients needed the comprehensive treatment that is provided in an OTP. “We didn’t want just dispensers, we wanted someone who was an advocate” for the patients, he said.

In addition, buprenorphine is much more expensive than methadone, and since Mountain Health Solutions doesn’t accept Medicaid, it could offer treatment only to people who could afford it, he said. So eventually, what was a buprenorphine clinic became a full-scale OTP in North Wilkesboro.

The doctors in Wilkes County and other counties were among the most vocal opponents of methadone and buprenorphine—at first. In one meeting with them and Jana Burson, MD, from the OTP, one doctor said he didn’t want “those people in the waiting room with Grandma,” Mr. Brason recalled. “I replied, ‘We are meeting right now in a church—and if this were Sunday morning, those people would be here.’” By the time the meeting was over, there was more understanding, at least of buprenorphine, said Mr. Brason, with some of the physicians agreeing to get a waiver so they could provide buprenorphine treatment.

Community Education

Mr. Brason provided education to the community about the importance of medication-assisted treatment during pregnancy, dispelling myths about neonatal abstinence syndrome (facts: NAS is transient and easily treatable, while withdrawing from opioids during pregnancy is harmful to the fetus). “Slowly, after a couple more years, methadone was introduced, and now they are serving more than 400 people a day in our tiny county,” he said. The vast majority are on methadone because they cannot afford buprenorphine.

There are now churches that are financially supporting their members for treatment—paying for the OTP and medications. “The church sees them, that they are going to church, they are going to work, they are supporting their families,” he said.

Mr. Brason is a chaplain, something that gives him credibility in the conservative South—maybe more credibility than a physician or scientist. In addition, he has worked extensively with a hospice in the area. “They know me and who I am,” he said. “That makes a difference.”

It’s still an uphill battle, he said; recently a county commissioner said that methadone clinics are a scam. Brason then sat down with a reporter and got a front page article showing that methadone treatment helps reduce overdose deaths. It was a public relations victory that benefited people who desperately needed help.

“We’ve had a for-profit private detox center all along,” said Mr. Brason. “We were losing people to overdose deaths 24 hours after detox.” That is much better now, because of the presence of the OTP.

Naloxone Kits

Opioid overdose deaths as a problem separate from addiction are also an important focus for Mr. Brason, who was able to introduce naloxone to Wilkes County. Through a grant from Purdue Pharma, the Lazarus Project was able to provide naloxone kits at no charge to the OTP. Originally, when the program started in 2009, this worked by the OTP writing prescriptions for the kits for all new patients—the first weeks on methadone are the riskiest for overdose, not from methadone but from other opioids as the patients are getting used to the doses. Then the patients would go to the pharmacy to pick up their prescription for the $50 kit. However, only 25 percent of the patients were actually getting these prescriptions filled. “They didn’t want to be seen at the pharmacy, they didn’t want the stigma,” he said. So he met with the OTP and agreed on a new system, in which Project Lazarus would pay for half the cost of the kit and the OTP would pay for the other half out of the patient’s enrollment fee. (The grant was over.) The OTP would write the prescription, and then send someone to the pharmacy to pick it up, giving it directly to the patient in the OTP

Spencer Clark, MSW, ACSW, who oversees OTPs for the North Carolina Division of Mental Health, Developmental Disabilities and Substance Abuse Services, has been very interested in the naloxone kits, said Mr. Brason. “He wondered if they could do this for every OTP in the state.” So far the OTP has documented four lives saved.

Mr. Brason sends naloxone kits to organizations, including first responders like police departments, across the country. The kits include the nasal atomizers, not the actual naloxone, which must be prescribed. Eventually, he hopes that first responders will be able to use the new auto-injector. “It will be great for them, they don’t have to put it together” like the kits, which come in a box. However, because it does involve a needle, some first responders will be more comfortable with the nasal spray, he said.

Rescuing someone from an overdose should mean that person gets access to treatment, said Mr. Brason. First of all, they will—it is hoped—go to the emergency department to get checked out after the rescue. “We approach the link to treatment by tying all the services together. We get our crisis intervention teams to that person within an hour” of the rescue, he said. The crisis counselor interviews the individual to figure out the next steps.

For more information on ordering the kits ($12), go to info@projectlazarus.org. Project Lazarus has covered the shipping charges. For more general information on Project Lazarus, go to http://projectlazarus.org/.

Naloxone ‘Stigma’ a Barrier to Prescribing?

“Although giving out naloxone to patients at high risk of overdose sounds like a good idea, researchers who work with the drug say the stigma surrounding its use may be a barrier to wider uptake among both patients and doctors.

Patients may feel they’re being treated like addicts and that their opioid prescriptions will be tempered, while doctors worry that just talking about naloxone may scare patients away, said Caleb Banta-Green, PhD, MPH, of the University of Washington in Seattle. “Both doctors and patients feel like they’re under the microscope,” Banta-Green told MedPage Today. “It’s a very sensitive time.”

Banta-Green and his colleagues are enrolling patients at high risk for opioid overdose — both heroin users and patients on prescription opioids — in a randomized trial to test whether providing naloxone, along with education and counseling, can reduce overdose.”

http://www.medpagetoday.com/Psychiatry/Addictions/45164

Source: MedPageToday.com – April 9, 2014

U.S. Attorney General Holder Urges Use of Drug to Help In Heroin ODs

Attorney General Eric Holder declaring heroin addiction is an “urgent and growing public health crisis,” urged first responders to carry the drug naloxone that helps resuscitate victims from an overdose.

“Addiction to heroin and other opiates — including certain prescription pain-killers — is impacting the lives of Americans in every state, in every region, and from every background and walk of life — and all too often, with deadly results,” Holder said in a video message posted Monday on the Justice Department website.”

http://www.usatoday.com/story/news/politics/2014/03/10/holder-heroin-overdose-help/6247281/

Source: USAToday.com – March 10, 2014

Wider Use of Antidote Could Lower Overdose Deaths by Nearly 50%

“Distributing naloxone and training people to use it can cut the death rates from overdose nearly in half, according to a new study.

The new study, published in the BMJ, followed the expansion of Overdose Education and Naloxone Distribution (OEND) programs in Massachusetts.  The programs were offered at emergency rooms, primary care centers, rehabilitation centers, support groups for families of addicted people and other places that might attract those at risk.

The study involved 2912 people in 19 different Massachusetts communities — each of which had had at least 5 opioid overdose deaths between 2004 and 2006.  The participants were trained to recognize overdose, call 911 and administer naloxone using a nasal inhaler.  If the naloxone didn’t work, they were instructed to try another dose and perform rescue breathing until help arrived.

During that time, 153 naloxone-based rescues were reported for which there was data on outcomes, and in 98% of those cases, the drug revived the victim.

There are still practical barriers however, to widely distributing naloxone and implementing more OEND type programs. Advocates have argued that the medication should be made available over-the-counter since it has little potential for abuse and is nontoxic. The Centers for Disease Control (CDC), the director of the National Institute on Drug Abuse and even the drug czar’s office support making it more widely available, and unlike the case with needle exchange programs, there has been no organized opposition to OEND. But the Food and Drug Administration (FDA) has no precedent for allowing over-the-counter sales of such a drug: naloxone is a generic medication approved in an injectable form. Without a company to submit an application for its use in the intranasal version, the agency isn’t likely to OK over-the-counter sales.”

http://healthland.time.com/2013/02/05/wider-use-of-antidote-could-lower-overdose-deaths-from-by-nearly-50/

Source: HealthlandTime.com – February 5, 2014

Role of Police in Responding to Overdoses Often Unclear: Study

hospital sign“The role of police officers in responding to overdoses is often unclear, according to a new study. Researchers say training officers in administering the overdose antidote naloxone could have a significant impact on the death rate from drug-related fatalities.

The study found that while police officers often serve as medical first responders, it is often unclear what police can or should do at the scene of an overdose, PsychCentral.com reports.

The researchers interviewed 13 law enforcement officials in Connecticut and Rhode Island communities experiencing high rates of drug overdoses. They found officials were supportive of being involved in overdose prevention, but they expressed hesitancy about laypersons administering naloxone. Officers said they were frustrated with their current overdose response options, the lack of accessible drug treatment, the cycle of addiction and the pervasiveness of easily accessible prescription opioid medications in their communities.”

http://www.drugfree.org/join-together/community-related/role-of-police-in-responding-to-overdoses-often-unclear-

Source: JoinTogether.org – September 30, 2013

Legal Interventions to Reduce Overdose Mortality: Naloxone Access and Overdose Good Samaritan Laws

“Opioid overdose is typically reversible through the timely administration of the drug naloxone and the provision of emergency care. However, access to naloxone and other emergency treatment is often limited by laws and that pre-date the overdose epidemic. In an attempt to reverse this unprecedented increase in preventable overdose deaths, a number of states have recently amended those laws to increase access to emergency care and treatment for opiate overdose.”

The Network for Public Health Law has published an update on access to naloxone by state and Good Samaritan laws.

http://www.networkforphl.org/_asset/qz5pvn/network-naloxone-10-4.pdf

Source: Network for Public Health Law – May, 2013

Study: Distributing Naloxone Injection Kits Could Help Addicts Reverse Heroin Overdoses

Distributing a drug that reverses drug overdoses in heroin users would save lives and be cost-effective, according to a new analysis.

U.S. researchers, who published their findings in the Annals of Internal Medicine on Monday, calculated that one death may be prevented for every 164 naloxone injection kits they distribute to heroin users. That, the researchers say, works out to be a few hundred dollars for every year of healthy life gained.

“The great news here is these overdose deaths can be prevented, it’s cost effective to do so, and may even be cost saving,” said Dr. Phillip Coffin, the study’s lead author from the San Francisco Department of Public Health.

http://medcitynews.com/2012/12/study-distributing-naloxone-injection-kits-could-help-addicts-reverse-heroin-overdoses/

Source: MedCityNews.com – December 31, 2012

Preventing Overdose: Obama Administration Drug Czar Calls for Wider Access to Overdose Antidote

governmentSpeaking at a North Carolina overdose-prevention program, the Obama administration’s drug czar Gil Kerlikowske called for increased action to prevent drug overdose deaths. Notably, for the first time Kerlikowske urged wider distribution of a medication called naloxone, an antidote to overdoses of opioid drugs, including prescription pain relievers and heroin, saying that “naloxone can be expanded beyond public health officials.”

http://healthland.time.com/2012/08/22/preventing-overdose-obama-administration-drug-czar-calls-for-wider-access-to-overdose-antidote/

Source: Healthland.Time.com – August 22, 2012

OTC Naloxone? It’s Possible

FDA officials are considering whether naloxone should be more widely available beyond medical settings, including through over-the-counter (OTC) sales and/or an intranasal version of the drug.

 “Certainly, considering naloxone as an over-the-counter drug is forging new territory,” said Andrea Leonard-Segal, MD, director, FDA Division of Nonprescription Clinical Evaluation, Office of Nonprescription Products. Classifying the drug OTC would probably be accomplished through the new drug application (NDA) process, she said. To accomplish it by FDA rulemaking would take years. The NDA process for switching to OTC classification, she said, would require a fresh look at the drug’s chemistry, pharmacology/toxicology, microbiology, and clinical pharmacology. There might not be a need for efficacy data if a current formulation were used, she said.

http://drugtopics.modernmedicine.com/drugtopics/Modern%2BMedicine%2BNow/OTC-naloxone-Its-possible/ArticleStandard/Article/detail/772754?contextCategoryId=40159

Source:  DrugTopics.com – May 15, 2012

Government Considers Overdose Antidote, Naloxone, to Fight Prescription Drug Misuse

The U.S. Food and Drug Administration (FDA) has for the first time advocated considering the distribution of the naloxone, an overdose antidote, as a way to curb the rising toll of overdose deaths in America.

The director of the National Institute on Drug Abuse, Dr. Nora Volkow, has said that the drug should be available without a prescription.

http://healthland.time.com/2012/04/27/government-considers-overdose-antidote-naloxone-to-fight-prescription-drug-misuse/

Source: Healthland.Time.com – April 27, 2012

Naloxone (Narcan) in the News

Naloxone Debate: FDA Hears Testimony About Making an Overdose Antidote Nonprescription

Parents testified at an open meeting called by the FDA to consider whether the lifesaving antidote to opioid overdose — a non-addictive, non-toxic drug called
naloxone (Narcan) — should be made available over-the-counter, so that everyone can keep it in their first aid kit, just in case.

The meeting was sponsored by the FDA, the Centers for Disease Control and Prevention (CDC) and the National Institute on Drug Abuse, whose director, Dr. Nora Volkow, has said that she supports making the drug available without a prescription.

http://healthland.time.com/2012/04/13/naloxone-debate-fda-hears-testimony-about-making-an-overdose-antidote-nonprescription/

Source: Time Healthland.com – April 13, 2012

Antidote (Naloxone) Hard To Find As Heroin Death Toll Rises

In the face of the rising death toll, the state of Washington in 2010 made the lifesaving opiate antidote Naloxone available by prescription. The drug, also known by several brand names, has long been used by paramedics and emergency-room doctors to pull overdose victims back from the brink of death.

It’s legal, but it’s not widely available, said Caleb Banta-Green, a research scientist at the University of Washington’s Alcohol and Drug Abuse Institute. “It’s an issue of needing enough demand. People don’t know to ask for it,” he said.

http://www.yakima-herald.com/stories/2012/04/06/antidote-hard-to-find-as-heroin-death-toll-rises

Source: Yakima-Herald.com – April 6, 2012

CDC Report: Community-Based Opioid Overdose Prevention Programs Providing Naloxone – U.S., 2010

Since the mid-1990s, community-based programs have offered opioid overdose prevention services to persons who use drugs, their families and friends, and service providers. Since 1996, an increasing number of these programs have provided the opioid antagonist naloxone hydrochloride, the treatment of choice to reverse the potentially fatal respiratory depression caused by overdose of heroin and other opioids.

In October 2010, the Harm Reduction Coalition, a national advocacy and capacity-building organization, surveyed 50 programs known to distribute naloxone in the United States, to collect data on local program locations, naloxone distribution, and overdose reversals. This report summarizes the findings for the 48 programs that completed the survey and the 188 local programs represented by the responses. Since the first opioid overdose prevention program began distributing naloxone in 1996, the respondent programs reported training and distributing naloxone to 53,032 persons and receiving reports of 10,171 overdose reversals.

Nineteen (76.0%) of the 25 states with 2008 drug overdose death rates higher than the median and nine (69.2%) of the 13 states in the highest quartile did not have a community-based opioid overdose prevention program that distributed naloxone.

Twenty-one (43.7%) responding programs reported problems obtaining naloxone in the “past few months” before the survey. The most frequently reported reasons for difficulties obtaining naloxone were the cost of naloxone relative to available funding and the inability of suppliers to fill orders.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6106a1.htm?s_cid=mm6106a1_w

Source: Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report (MMWR) – February 17, 2012

FDA Calls for Public Comments on Wider Distribution of Naloxone for Opioid Overdose Fatality Prevention

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), in collaboration with the Office of the Assistant Secretary for Health, National Institutes of Drug

Abuse, and the Centers for Disease Control and Prevention, is announcing a scientific workshop to initiate a public discussion about the potential value of making naloxone more widely available outside of conventional medical settings to reduce the incidence of opioid overdose fatalities.

http://www.gpo.gov/fdsys/pkg/FR-2011-11-17/pdf/2011-29703.pdf

Source: Federal Register / Vol. 76, No. 222 / Thursday, November 17, 2011 / Notices

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