FDA Approves New Injectable Naloxone

By: Marcus J. Hopkins, Policy Consultant

The U.S. Food & Drug Administration (FDA) has approved a new injectable form of naloxone hydrochloride – an antagonist used to reverse the effects of an opioid (House, 2019).
India-based Aurobindo Pharma, Ltd. received approval for its injectable naloxone in early November 2019 from the FDA at a time when certain areas of the U.S. – primarily those located in areas where opioid-related drug overdoses are high – are facing shortages of naloxone (Sharpless, 2019).

Photo Source: NPR

Injectable naloxone, as per FDA requirements, require a prescription for distribution in most states, although some states and pharmacies have suspended that requirement (Marsh, 2018). It is also more difficult for people to administer than the nasal spray version, Narcan, which retails at an average retail price of $140.48 (GoodRX, n.d.). The FDA did, however, approve a generic version of the nasal spray from Israel-based Teva Pharmaceutical Industries, Ltd. in May 2019 (Ducharme, 2019), although Teva has not yet announced their pricing on the generic, nor a street date for its release.

The U.S. continues to see annual increases in drug overdose deaths overwhelmingly driven by opioid-related overdose deaths, primarily heroin and fentanyl, a synthetic opioid drug that has increasingly been finding its way into supplies of heroin, counterfeit prescription drugs, and supplies of other illicit drugs such as methamphetamine. The states with the highest rates of drug overdose deaths – West Virginia, Ohio, Pennsylvania, and Kentucky in particular – have large swaths of the states where there is a convergence of opioid overdose deaths, Injection Drug Use (IDU), infectious disease spread via IDU, and a lack of easy access to medical and healthcare services.

As a result of the increasing rates and incidence of overdose deaths, states and municipalities have responded by authorizing (and in some cases, requiring) that state employees be trained and begin carrying naloxone in their places of employment, including local and state offices, schools, and state buildings. These requirements are put in place in anticipation that, given the widespread rate of opioid addiction, someone may overdose in these buildings at some time and require naloxone administration in an attempt to save their lives.

References:

• Ducharme, J. (2019, April 19). The FDA Just Approved the First Generic Nasal Spray to Reverse Opioid Overdoses. New York City, NY: Time USA, LLC.: Time: Health: Drugs. Retrieved from: https://time.com/5574107/fda-generic-naloxone-nasal-spray/
• GoodRx. (n.d.). Narcan. Santa Monica, CA: GoodRx. Retrieved from: https://www.goodrx.com/narcan
• House, D. W. (2019, November 06). FDA OKs Aurobindo's naloxone for opioid overdose. Ra’anana, Israel. Seeking Alpha: Healthcare. Retrieved from: https://seekingalpha.com/news/3515511-fda-oks-aurobindos-naloxone-opioid-overdos
• Marsh, T. (2018, June 04). Here’s How to Get Naloxone, the Opioid Overdose Antidote, Without a Prescription. Santa Monica, CA: GoodRx: Blog. Retrieved from: https://www.goodrx.com/blog/heres-how-to-get-naloxone-the-opioid-overdose-antidote-without-a-prescription
• Sharpless, N. E. (2019, September 20). Statement on continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths. Rockville, MD: U.S Food & Drug Administration: News & Events: FDA Newsroom: Press Announcements. Retrieved from: https://www.fda.gov/news-events/press-announcements/statement-continued-efforts-increase-availability-all-forms-naloxone-help-reduce-opioid-overdose

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Annual National Monitoring Report on HIV/HCV Co-Infection

By: Marcus J. Hopkins, Project Director, HIV/HCV Co-Infection Watch, Community Access National Network (CANN)

The ADAP Advocacy Association is sponsoring an important community roundtable on September 22nd in Washington, DC, hosted by the Community Access National Network (CANN). The pressing issue at hand: HIV/HCV Co-Infection. The First Annual National Monitoring Report on HIV/HCV Co-Infection will present findings on the state of human immunodeficiency virus (HIV) and hepatitis C (HCV) co-infection in the United States, including a summary of the HIV/HCV Co-Infection Watch, as well as the HealthHIV/HealthHCV recently published report, State of HCV Care National Survey.

The event will be held at the Pharmaceutical Research and Manufacturers of America (PhRMA) Headquarters, located at 950 F St., NW Suite 300, Washington, DC 20004. It will be held from 3:00 PM – 5:00 PM (EST). Gilead, Merck and Walgreens are also sponsoring this event, along with PhRMA.

While both HIV and HCV are significant health issues on their own, co-infection poses a serious threat to persons living with HIV. Treating HCV in conjunction with HIV can be difficult, as many of the most popular HIV combination therapies (such as Stribild) may have serious drug interactions with some of the components of newer Direct Acting Agents (DAAs) currently available to cure HCV.

Recent spikes in HCV infections related to Injection Drug Use (IDU) have led physicians in affected areas to screen also for HIV. Perhaps the most well-publicized case involved an outbreak in Scott County, Indiana, was caught due to a sharp increase in HCV infections amongst IDUs. The outbreak also led the state’s conservative legislature to approve emergency Harm Reduction measures – namely Syringe Exchanges – in counties designated as having public health emergencies. The sixth such emergency Syringe Exchange will be opening in Clark County, this fall. Clark County, which neighbors Scott County, has seen a 63% increase in fatal drug overdoses since 2013, with 49 confirmed fatal overdoses, and another 20 pending since the beginning of the year (Maher, 2016).

The HIV/HCVCo-Infection Watch released its inaugural Report in January 2015, originally focusing only on HCV drug coverage in AIDS Drug Assistance Programs (ADAPs) and Medicaid programs. Now, nearing the end of its second year in publication, the Watch has expanded to include coverage information for the Veteran’s Affairs (VA), Harm Reduction measures (including Syringe Exchanges) to prevent the spread of infection, and regional trends, which focus on issues of drug coverage, co-infection, and legislative efforts to combat the spread of HCV. Each Report also contains the latest news in HCV science, opioid/heroin addiction, pharmaceutical updates, and HIV/HCV-related news.

 HealthHIV’s report on the State of Hepatitis C Care National Survey was released in February 2016, and presents the findings gathered during the survey process. The inaugural survey, conducted in 2015 in conjunction with Medscape, LLC., collected data on both providers and the patient populations they serve, and made policy recommendations and observations related to increasing access to HCV care both outside and within the HIV care continuum.

 While the National Monitoring Report on HIV/HCV Co-Infection event is free to attend, seating is limited. Advanced registration is required, which can be done at the following web address: https://www.123signup.com/event?id=njrck.

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Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Combatting the Dual Epidemic of Substance Use and HIV-Infection

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

Since the earliest days of the AIDS epidemic, there has been a significant link between substance use, abuse, and dependence and HIV-infection. Aside from injection drug use ("IDU") -- which can cause direct exposure to the virus -- substance use, abuse, and dependance "can affect people’s overall health and make them more susceptible to HIV infection and, in those already infected with HIV, substance use can hasten disease progression and negatively affect adherence to treatment."[1]

Photo Source: We Do Recover

According to the CDC, some of the populations most vulnerable populations include people who live in disadvantaged neighborhoods, gay, bisexual and transgender men, people with mental illness, and people who have experienced sexual, physical, or emotional abuse. Among some of the most common substances used are alcohol, crack cocaine, heroin, Methamphetamine ("Meth"), and poppers.[2]

Unfortunately, many prevention strategies -- otherwise known has Harm Reduction -- often fall victim to the political kickball because many right wing conservatives view them as condoning drug use. Also, often the scarcity of available funding in public health can push these programs to the back burner. The lack of prevention dollars has long plagued the fight against the AIDS epidemic, and it is one that continues today (though some progress has been achieved over the last decade in this area).

To that end, earlier this month the National Alliance of State & Territorial AIDS Directors (NASTAD) released a Fact Sheet on ADAP Formulary Coverage of Substance Use Treatment. The fact sheet demonstrates how AIDS Drug Assistance Programs (ADAPs) cover substance use treatment medications, related client services, as well as drug-specific information for medications.[3]

It includes the following sections:

• Substance Use Treatment Needs among PLWH
• Use of Ryan White Part B and ADAP Funds to Expand Access to Substance Use Treatment
• Substance Use Treatment Medications: Drug-Specific Information

NASTAD summarized the important role played by ADAPs: "When used in combination with behavioral therapy, substance use treatment medications allow individuals to manage addiction or dependency by reducing their risk for overdose, cravings, and/or symptoms of withdrawal.  For PLWH who use substances, these treatments bolster multiple “bars” within the HIV care continuum, including adherence to ARV treatment and viral load suppression."[4] 

The fact sheet can be downloaded online at https://www.nastad.org/resource/adap-formulary-coverage-substance-use-treatment.

There is no one-size-fits-all to the prevention and treatment of substance use, abuse, and dependence. One thing is certain though, there isn't enough being done in this area. Resources and tools -- such as the one made available by NASTAD -- are important to community leaders trying to tackle the dual epidemic of substance use and HIV-infection.

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[1] U.S. Centers for Disease Control & Prevention (CDC), "HIV and Substance Use in the Unite," March 2013; available online at http://www.cdc.gov/hiv/pdf/risk_HIV_Substance.pdf.
[2] U.S. Centers for Disease Control & Prevention (CDC), "HIV and Substance Use in the Unite," March 2013; available online at http://www.cdc.gov/hiv/pdf/risk_HIV_Substance.pdf.
[3] National Alliance of State & Territorial AIDS Directors (NASTAD), "ADAP Formulary Coverage of Substance Use Treatment," July 5, 2016; available online at https://www.nastad.org/resource/adap-formulary-coverage-substance-use-treatment.
[4] Bowes, Amanda, National Alliance of State & Territorial AIDS Directors (NASTAD), "AIDS DRUG ASSISTANCE PROGRAMS’ (ADAPS) SUPPORT OF SUBSTANCE USE TREATMENT FOR THE CLIENTS THEY SERVE," July 5, 2016; available online at https://www.nastad.org/blog/aids-drug-assistance-programs-adaps-support-substance-use-treatment-clients-they-serve.