Tag: opioid antidote

Inside The Push For Over-The-Counter Naloxone

The FDA has recently taken an unprecedented step to kickstart the development of over-the-counter naloxone products.

Last week the FDA took an unprecedented step to make the anti-overdose drug naloxone directly available to opioid users.

Currently, naloxone requires a prescription. But in an effort to make approval for non-prescription versions of the drug easier for pharmaceutical companies to get, the FDA developed sample labels that would meet federal Drug-Facts Label requirements for over-the-counter products. It marks the first time the drug agency has ever proactively created labelling to expedite the process.

“Naloxone is a critical drug to help reduce opioid overdose deaths. Prevention and treatment of opioid overdose is an urgent priority,” the agency wrote in an unsigned statement. “Increased availability of naloxone for emergency treatment of overdoses is an important step.”

The agency created two model labels, one for a nasal spray version of the drug and one for an auto-injector version. Both versions include a short information box about the drug and its uses, followed by an illustrated guide on how to administer the life-saving treatment and a warning about the drug’s expected effects.

“These efforts should jumpstart the development of OTC naloxone products to promote wider access to this medicine,” the FDA wrote. The agency tested the labeling through a research contractor to verify that potential users could understand the images and warnings.

“This work builds on our ongoing efforts to get this life-saving drug into the hands of those who need it most,” the statement continued. “In addition to the approval of injectable naloxone for use in a health care setting and both prescription auto-injector and intranasal forms of naloxone, which facilitate use by laypersons, we also released draft guidance to advance development of generic naloxone hydrochloride nasal spray.”

The move comes amid a long-term rise in overdose deaths, as close to 48,000 people died from opioids in 2017 – double what the figure was seven years earlier, according to the federal agency. Overdoses can cause drug users to lose consciousness and stop breathing, but naloxone reverses those effects if given quickly enough.

Though the injectable version is pricier, a two-pack of the brand-name nasal spray version sells for about $125, according to CNBC. The generic is around $40 per dose. In theory, offering up a label that could make over-the-counter access easier might help lower those figures further by eliminating the need for would-be buyers to spend money on seeing a doctor for a prescription.

“While the person administering naloxone should also seek immediate medical attention for the patient,” the agency said, “the bottom line is that wider availability of naloxone and quick action to administer it can save lives.”

View the original article at thefix.com

22 January 2019
Naloxone Price Spiked 600% During Opioid Crisis By Drug Maker

One drug manufacturer reportedly increased the price of its naloxone drug Evzio from $575 per dose to $4,100 per dose.

Naloxone, the opioid overdose reversal drug, has been heralded as a lifesaving intervention credited with helping stem the death toll of the opioid epidemic. However, one drug manufacturer reportedly saw the demand for the drug as a lucrative opportunity, raising its price 600% over the past four years.

According to a report commissioned by Sens. Rob Portman (R-OH) and Tom Carper (D-DE), drug manufacturer Kaléo “exploited the opioid crisis” by increasing the price of its naloxone drug Evzio from $575 per dose to $4,100 per dose.

Naloxone can save people’s lives during opioid overdoses by reversing the effects of opioids. Sometimes, in the case of powerful synthetic opioids like fentanyl, multiple doses need to be administered.

According to the report, Kaléo intentionally increased the price of Evzio, in addition to manipulating how the drug was processed by insurance companies to take advantage of a money-making opportunity.

“In conjunction with the price increase, Kaléo launched its new business plan,” the report reads. “The Evzio Commercial Update Executive Summary, pictured here, dated April 2016, noted ‘2016 is critical to long-term success.’ With the increased price and new business model, Kaléo sought to ‘[c]apitalize on the opportunity’ of ‘opioid overdose at epidemic levels—a well-established public health crisis.’”

The report concluded that Kaléo’s aggressive pricing cost taxpayers $142 million through payments made through Medicare and Medicaid, according to a press release from Portman’s office.

“Naloxone is a critically important overdose reversal drug that our first responders have used to save tens of thousands of lives,” Portman said. “The fact that one company dramatically raised the price of its naloxone drug and cost taxpayers tens of millions of dollars in increased drug costs, all during a national opioid crisis no less, is simply outrageous. The Subcommittee will continue its efforts to protect taxpayers from drug manufacturers that are exploiting loopholes in the Medicare and Medicaid system in order to profit from a national opioid crisis.”

Carper agreed, saying, “We know that naloxone can save lives. We need to take the necessary steps to ensure that drugs like this are affordable and accessible to those in need, especially during a public health emergency of this magnitude.”

In response to the report, Kaléo issued a statement pointing out that it has donated thousands of doses of Evzio, and claimed that it has never turned a profit from the drug.

“Patients, not profits, have driven our actions,” the company said.

Read more about the report’s findings and how Kaléo manipulated pricing here.

View the original article at thefix.com

22 November 2018
Will Naloxone Be Co-Prescribed With Opioid Painkillers In The Future?

While some states already require the co-prescription, the FDA is considering making it a requirement across the US.

In an effort to decrease overdose deaths, doctors could soon be required to prescribe an opioid overdose antidote any time they prescribe prescription painkillers, according to Food and Drug Administration (FDA) Commissioner Scott Gottlieb.

The idea of co-prescription, according to the Washington Examiner, isn’t a new idea. In fact, some states such as Arizona, Virginia, and Vermont, already require the co-prescription of the overdose reversal drug known as naloxone.

Naloxone comes in the form of a nasal spray as well as an auto-injection so it may be administered by those not in the medical field.

Other states considering such laws include California, Florida, New York, Ohio, Texas, and Utah.

Such laws are supported by the manufacturers of popular overdose antidotes, such as Adapt Pharma, the company that distributes Narcan.

“We are trying to do anything we can to build awareness and broaden support,” said company chairman and CEO Seamus Mulligan, according to the Examiner.

Kaleo, the manufacturer of the naloxone auto-injector, is also supportive, telling the Examiner in May that it “welcomes” the idea of co-prescribing.

“We believe that doctors, pharmacists and other healthcare professionals play a critical role in developing and managing a comprehensive treatment plan for their patients, as well as helping a patient and their loved ones recognize the potential risk for opioid emergencies, even when pain medications are taken as directed,” the company said.

Current laws vary from state to state. In Vermont, prescription rules are connected to other laws requiring doctors to check patient databases before prescribing an opioid.

In Virginia, it’s recommended that high doses of pain prescriptions are given with an overdose antidote prescription as well.

Additionally, doctors are encouraged to prescribe the antidote when prescribing opioids and benzodiazepines, as the two can lead to overdose.

The Centers for Disease Control and Prevention (CDC) has made similar recommendations in its guidelines to doctors.

While naloxone can save lives, it’s not considered a treatment for substance use disorder.

“Naloxone allows someone another day to have an opportunity to overcome their addiction,” New York state Sen. George Amedore Jr. said, according to the Examiner. “It’s not the whole answer or the cure-all.”

As such, some officials are also calling for wider access to buprenorphine, a medication that helps to lessen cravings and withdrawals.

The FDA will hold a meeting on Dec. 17-18 to determine more ways to make the overdose antidote more readily available.

View the original article at thefix.com

24 October 2018
Opioid Antidote Naloxone Recalled By Manufacturer

A batch of units sold between February 2017 and February 2018 are being recalled by the manufacturer.

The life-saving opioid overdose antidote naloxone has been recalled by its manufacturer, the Food and Drug Administration (FDA) announced.

Drug company Hospira and its parent company Pfizer issued the recall on Monday, CNN reported, after discovering “loose particulate matter on the syringe plunger.”

While no one has yet reported problems with the drug, Pfizer isn’t taking any chances. “In the event that impacted product is administered to a patient, the patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity,” the drug maker said in its recall.

Known by its brand name Narcan, naloxone has made headlines in recent years for its role in the nation’s opioid crisis, as it rapidly reverses the effects of overdoses.

The drug is widely carried by ER doctors, paramedics and specially trained first responders, as well as the family members of people addicted to prescription painkillers and opioid users. (Previously, the drug was only available through hospitals, CNN noted.)

First developed in 1961, naloxone quickly proved itself to be as effective as it is fast-acting. The drug has virtually no side effects and only stays in a person’s system for up to 90 minutes.

“The sooner the drug is given, the better the result, because the brain of a person who isn’t breathing is being deprived of oxygen,” the Cleveland Clinic’s Dr. Thomas Waters told Health. It doesn’t reverse alcohol or non-opioid drug overdoses, though.

There are currently three FDA-approved forms of naloxone, including injectable vials, autoinjectable devices and a pre-packaged nasal spray.

According to the National Institute on Drug Abuse, naloxone acts as an opioid antagonist, binding to opioid receptors in the brain: “[The drug] can very quickly restore normal respiration to a person whose breathing has slowed or stopped as a result of overdosing with heroin or prescription opioid pain medications.”

The drug recall affects single-use sterile cartridge units “with lot numbers 72680LL and 76510LL in 0.4 mg/ml, 1 mL in, and 2.5 mL strengths,” CNN reports.

CNN added that the units were sold to wholesalers, hospitals and distributors in the United States, Puerto Rico and Guam between February 2017 and February 2018.

Fortune noted that the naloxone recall is just “the latest black eye” for Hospira, citing manufacturing shortages, lawsuits, staff cuts and warning letters from the FDA as problems that have plagued the company in recent years. The company’s Puerto Rico facilities, where many generic injectable and IV drugs were made, were shuttered after the “bombshell of Hurricane Maria” last year.

View the original article at thefix.com

7 June 2018