Matching articles for "opioid dependence"
In Brief: Over-the-Counter Narcan Nasal Spray
The Medical Letter on Drugs and Therapeutics • May 1, 2023; (Issue 1675)
The FDA has approved the over-the-counter (OTC)
sale of Narcan (Emergent), a nasal spray that delivers
4 mg of the opioid antagonist naloxone. Narcan nasal
spray has been available by prescription since...
The FDA has approved the over-the-counter (OTC)
sale of Narcan (Emergent), a nasal spray that delivers
4 mg of the opioid antagonist naloxone. Narcan nasal
spray has been available by prescription since 2015
for emergency treatment of opioid overdose. Generic
formulations of Narcan have also been approved; the
manufacturers of these products will be required to
switch them to OTC status and amend their labeling
accordingly. Kloxxado, an 8-mg naloxone nasal
spray, remains available only by prescription.
Opioids for Pain
The Medical Letter on Drugs and Therapeutics • December 12, 2022; (Issue 1665)
A new CDC guideline for prescribing opioids for pain
recently became available. Nonopioid drugs for pain
were reviewed in a previous...
A new CDC guideline for prescribing opioids for pain
recently became available. Nonopioid drugs for pain
were reviewed in a previous issue.
Nalmefene Returns for Reversal of Opioid Overdose
The Medical Letter on Drugs and Therapeutics • September 5, 2022; (Issue 1658)
The FDA has approved a generic injectable formulation
of the opioid antagonist nalmefene (Purdue) for the
management of known or suspected opioid overdose.
Revex, the reference product, was withdrawn from...
The FDA has approved a generic injectable formulation
of the opioid antagonist nalmefene (Purdue) for the
management of known or suspected opioid overdose.
Revex, the reference product, was withdrawn from the
market in 2008 for commercial reasons.
Zimhi - A Higher-Dose Injectable Naloxone for Opioid Overdose
The Medical Letter on Drugs and Therapeutics • April 18, 2022; (Issue 1648)
The FDA has approved a higher-dose injectable
formulation of the opioid antagonist naloxone
(Zimhi – Adamis) for emergency treatment of opioid
overdose. A single IM or SC injection of the new
formulation...
The FDA has approved a higher-dose injectable
formulation of the opioid antagonist naloxone
(Zimhi – Adamis) for emergency treatment of opioid
overdose. A single IM or SC injection of the new
formulation delivers 5 mg of naloxone; injectable
formulations that deliver 0.4 mg or 2 mg of the drug
have been available for years. Naloxone is also
available in intranasal formulations for the same
indication (see Table 1).
In Brief: Higher-Dose Naloxone Nasal Spray (Kloxxado) for Opioid Overdose
The Medical Letter on Drugs and Therapeutics • September 20, 2021; (Issue 1633)
The FDA has approved a higher-dose intranasal
naloxone formulation (Kloxxado – Hikma) for
emergency treatment of opioid overdose. A single
spray of the new formulation delivers 8 mg of
naloxone; a...
The FDA has approved a higher-dose intranasal
naloxone formulation (Kloxxado – Hikma) for
emergency treatment of opioid overdose. A single
spray of the new formulation delivers 8 mg of
naloxone; a formulation that delivers 4 mg per spray
(Narcan) was approved in 2015.
Clarification: Management of Opioid Withdrawal Symptoms
The Medical Letter on Drugs and Therapeutics • December 3, 2018; (Issue 1561)
Some readers have questioned our characterization of opioid withdrawal as not life-threatening (Med Lett Drugs Ther 2018; 60:137). While death during opioid withdrawal is unusual, it is possible — for...
Some readers have questioned our characterization of opioid withdrawal as not life-threatening (Med Lett Drugs Ther 2018; 60:137). While death during opioid withdrawal is unusual, it is possible — for example, due to severe untreated dehydration, withdrawal-induced suicidality, or rare myocardial events. We probably should have said that opioid withdrawal is generally not life-threatening. We will make that addition to the article as it appears on our website.
Roxybond - An Abuse-Deterrent Formulation of Short-Acting Oxycodone
The Medical Letter on Drugs and Therapeutics • September 10, 2018; (Issue 1555)
The FDA has approved Roxybond (Daiichi Sankyo), an
short-acting (SA) oxycodone formulation with
abuse-deterrent properties, for treatment of pain
requiring management with an opioid. Roxybond
is the first...
The FDA has approved Roxybond (Daiichi Sankyo), an
short-acting (SA) oxycodone formulation with
abuse-deterrent properties, for treatment of pain
requiring management with an opioid. Roxybond
is the first SA opioid to be approved as an abuse-deterrent
product. Oxaydo, another IR oxycodone
formulation, has properties that discourage its
intranasal and intravenous use, but is not considered
an abuse-deterrent product by the FDA. Use of
opioids for treatment of pain was reviewed in a
recent issue.
Management of Opioid Withdrawal Symptoms
The Medical Letter on Drugs and Therapeutics • August 27, 2018; (Issue 1554)
Pharmacologic management of opioid withdrawal
symptoms can reduce the intensity of drug craving
and improve treatment retention in patients with opioid
use disorder who will receive maintenance...
Pharmacologic management of opioid withdrawal
symptoms can reduce the intensity of drug craving
and improve treatment retention in patients with opioid
use disorder who will receive maintenance treatment.
Withdrawal management without subsequent maintenance
treatment is associated with high rates of
relapse, overdose death, and HIV and/or hepatitis C
virus infection. Several guidelines on management
of opioid withdrawal are available. Maintenance
treatment of opioid use disorder was reviewed in a
previous issue.
Expanded Table: Some Drugs for Management of Opioid Withdrawal Symptoms (online only)
The Medical Letter on Drugs and Therapeutics • August 27, 2018; (Issue 1554)
...
View Expanded Table: Some Drugs for Management of Opioid Withdrawal Symptoms
Lofexidine (Lucemyra) for Opioid Withdrawal
The Medical Letter on Drugs and Therapeutics • July 16, 2018; (Issue 1551)
The FDA has approved lofexidine (Lucemyra – US
WorldMeds/Salix), a centrally acting alpha2 receptor
agonist, to manage withdrawal symptoms in adults
abruptly stopping opioid use. Available in the UK...
The FDA has approved lofexidine (Lucemyra – US
WorldMeds/Salix), a centrally acting alpha2 receptor
agonist, to manage withdrawal symptoms in adults
abruptly stopping opioid use. Available in the UK since
1992, lofexidine is the first nonopioid to be approved
in the US for management of opioid withdrawal
symptoms. Clonidine (Catapres, and generics), another
central alpha2 receptor agonist, has been used off-label
for this indication for many years.
Opioids for Pain
The Medical Letter on Drugs and Therapeutics • April 9, 2018; (Issue 1544)
Use of nonopioid drugs for pain was reviewed in a
previous issue. For many types of moderate to severe acute pain, acetaminophen and/or an NSAID may be as effective as an opioid. Immediate-release formulations...
Use of nonopioid drugs for pain was reviewed in a
previous issue. For many types of moderate to severe acute pain, acetaminophen and/or an NSAID may be as effective as an opioid. Immediate-release formulations of full opioid agonists should generally be used for acute pain that is severe enough to require treatment with an opioid. Use of extended-release or long-acting opioid formulations initially and treatment durations >1 week have been associated with an increased risk of unintended long-term use.
Once-Monthly Subcutaneous Buprenorphine (Sublocade) for Opioid Use Disorder
The Medical Letter on Drugs and Therapeutics • February 26, 2018; (Issue 1541)
The FDA has approved a subcutaneous (SC)
extended-release formulation of the mu-opioid
receptor partial agonist and kappa-opioid receptor
antagonist buprenorphine (Sublocade – Indivior)
for once-monthly...
The FDA has approved a subcutaneous (SC)
extended-release formulation of the mu-opioid
receptor partial agonist and kappa-opioid receptor
antagonist buprenorphine (Sublocade – Indivior)
for once-monthly treatment of moderate to severe
opioid use disorder. Sublocade is the first injectable
buprenorphine product to be approved in the US.
Buprenorphine is also available in sublingual
formulations with or without the opioid antagonist
naloxone, in a buccal formulation with naloxone, and
as a subdermal implant (Probuphine).
Drugs for Opioid Use Disorder
The Medical Letter on Drugs and Therapeutics • June 5, 2017; (Issue 1522)
Opioid use disorder is a chronic, relapsing disease with both physical and psychiatric components. It is
associated with economic hardship, social isolation,
incarceration, increased rates of...
Opioid use disorder is a chronic, relapsing disease with both physical and psychiatric components. It is
associated with economic hardship, social isolation,
incarceration, increased rates of blood-borne
infections such as HIV and viral hepatitis, adverse
pregnancy outcomes, and increased mortality.
According to the CDC, there were 33,091 deaths
related to opioid overdose in the US in 2015, more
than in any previous year. Several guidelines on the
management of opioid use disorder have recently
been published.
Abuse-Deterrent Opioids
The Medical Letter on Drugs and Therapeutics • June 5, 2017; (Issue 1522)
Development of abuse-deterrent opioid products,
including reformulation of existing products, has
become a priority for drug manufacturers and
public health advocates. Since our last article on
this...
Development of abuse-deterrent opioid products,
including reformulation of existing products, has
become a priority for drug manufacturers and
public health advocates. Since our last article on
this subject, several new abuse-deterrent opioid
formulations have been approved by the FDA,
including an oxycodone tablet formulation (Roxybond
– Inspirion) that is the first immediate-release opioid
product FDA-approved to include claims of abuse
deterrence in its labeling. No opioid formulation
prevents consumption of a large number of intact
dosage units, the most common method of abuse.
Abuse-deterrent formulations have one or more
properties that make their intentional nontherapeutic
use more difficult, less attractive, or less rewarding.
Buprenorphine Implants (Probuphine) for Opioid Dependence
The Medical Letter on Drugs and Therapeutics • July 18, 2016; (Issue 1499)
The FDA has approved subdermal implants of the partial
opioid agonist buprenorphine (Probuphine – Titan) for
maintenance treatment of opioid dependence in patients
stabilized on low to moderate doses of...
The FDA has approved subdermal implants of the partial
opioid agonist buprenorphine (Probuphine – Titan) for
maintenance treatment of opioid dependence in patients
stabilized on low to moderate doses of transmucosal
buprenorphine. Probuphine was designed to provide
continuous low levels of buprenorphine for 6 months
and to safeguard against illicit use of the drug.
Buprenorphine Buccal Film (Belbuca) for Chronic Pain
The Medical Letter on Drugs and Therapeutics • April 11, 2016; (Issue 1492)
Belbuca (Endo), a buccal formulation of the partial
opioid agonist buprenorphine, has been approved by the
FDA for management of pain severe enough to require
daily, around-the-clock, long-term opioid...
Belbuca (Endo), a buccal formulation of the partial
opioid agonist buprenorphine, has been approved by the
FDA for management of pain severe enough to require
daily, around-the-clock, long-term opioid treatment.
Buprenorphine is also available as a transdermal patch
(Butrans) and in a parenteral formulation (Buprenex, and
generics) for treatment of pain. A sublingual formulation
of buprenorphine and buccal and sublingual formulations
containing buprenorphine and the opioid antagonist
naloxone are approved for use as alternatives to
methadone for treatment of opioid dependence.
Bunavail: Another Buprenorphine/Naloxone Formulation for Opioid Dependence
The Medical Letter on Drugs and Therapeutics • February 2, 2015; (Issue 1461)
The FDA has approved a buccal film formulation of the
partial opioid agonist buprenorphine combined with
the opioid antagonist naloxone (Bunavail – BioDelivery
Sciences) for maintenance treatment of...
The FDA has approved a buccal film formulation of the
partial opioid agonist buprenorphine combined with
the opioid antagonist naloxone (Bunavail – BioDelivery
Sciences) for maintenance treatment of opioid
dependence. Sublingual tablet and film formulations
of the same combination were approved earlier. The
manufacturer of Bunavail claims that the new product
is superior to sublingual formulations because of
the convenience of buccal administration and better
absorption into the blood, permitting use of lower doses.
In Brief: Buprenorphine/Naloxone (Zubsolv) for Opioid Dependence
The Medical Letter on Drugs and Therapeutics • October 14, 2013; (Issue 1427)
A new sublingual tablet formulation of the partial opioid agonist buprenorphine combined with the opioid antagonist naloxone (Zubsolv – Orexo) has been approved by the FDA for maintenance treatment of opioid...
A new sublingual tablet formulation of the partial opioid agonist buprenorphine combined with the opioid antagonist naloxone (Zubsolv – Orexo) has been approved by the FDA for maintenance treatment of opioid dependence. Zubsolv tablets have relatively greater bioavailability than previously approved sublingual film (Suboxone) and sublingual tablet formulations of buprenorphine/naloxone and, according to an open-label survey, they taste better. The new tablets are smaller and dissolve faster than other tablet formulations, and they are individually sealed in child-resistant packaging.1
Buprenorphine is a Schedule III controlled substance that can be prescribed in an office setting by qualified physicians who register with the Substance Abuse and Mental Health Services Administration.2
Zubsolv is available as triangular tablets containing 1.4 mg of buprenorphine and 0.36 mg of naloxone and round tablets containing 5.7 mg of buprenorphine and 1.4 mg of naloxone, which achieve plasma concentrations of buprenorphine equivalent to those with the 2/0.5-mg and 8/2-mg strengths of other buprenorphine/naloxone tablets. A package of Zubsolv 5.7/1.4-mg tablets costs the same ($211) as a box of Suboxone 8/2-mg films. A bottle of generic buprenorphine/naloxone 8/2-mg tablets costs $250.3
1. A Fischer et al. Pharmaceutical and pharmacokinetic characterization of a novel sublingual buprenorphine/naloxone tablet formulation in healthy volunteers. Drug Dev Ind Pharm 2013 Oct 7 (epub).
2. Buprenorphine: an alternative to methadone. Med Lett Drugs Ther 2003; 45:13.
3. Approximate wholesale acquisition cost (WAC) of 30 tablets or films. Source: $ource® Monthly (Selected from FDB MedKnowledge™) October 5, 2013. Reprinted with permission by FDB, Inc. All rights reserved. ©2013. www.fdbhealth.com/policies/drug-pricing-policy. Actual retail prices may be higher.
Download complete U.S. English article
Buprenorphine is a Schedule III controlled substance that can be prescribed in an office setting by qualified physicians who register with the Substance Abuse and Mental Health Services Administration.2
Zubsolv is available as triangular tablets containing 1.4 mg of buprenorphine and 0.36 mg of naloxone and round tablets containing 5.7 mg of buprenorphine and 1.4 mg of naloxone, which achieve plasma concentrations of buprenorphine equivalent to those with the 2/0.5-mg and 8/2-mg strengths of other buprenorphine/naloxone tablets. A package of Zubsolv 5.7/1.4-mg tablets costs the same ($211) as a box of Suboxone 8/2-mg films. A bottle of generic buprenorphine/naloxone 8/2-mg tablets costs $250.3
1. A Fischer et al. Pharmaceutical and pharmacokinetic characterization of a novel sublingual buprenorphine/naloxone tablet formulation in healthy volunteers. Drug Dev Ind Pharm 2013 Oct 7 (epub).
2. Buprenorphine: an alternative to methadone. Med Lett Drugs Ther 2003; 45:13.
3. Approximate wholesale acquisition cost (WAC) of 30 tablets or films. Source: $ource® Monthly (Selected from FDB MedKnowledge™) October 5, 2013. Reprinted with permission by FDB, Inc. All rights reserved. ©2013. www.fdbhealth.com/policies/drug-pricing-policy. Actual retail prices may be higher.
Download complete U.S. English article
A Morphine/Naltrexone Combination (Embeda) for Pain
The Medical Letter on Drugs and Therapeutics • March 22, 2010; (Issue 1334)
The FDA has approved an agonist/antagonist combination of morphine and naltrexone (Embeda – King)
for treatment of chronic moderate to severe pain requiring around-the-clock analgesia for an extended
period...
The FDA has approved an agonist/antagonist combination of morphine and naltrexone (Embeda – King)
for treatment of chronic moderate to severe pain requiring around-the-clock analgesia for an extended
period of time. The addition of naltrexone is intended to prevent abuse of morphine.
Buprenorphine: An alternative to Methadone
The Medical Letter on Drugs and Therapeutics • February 17, 2003; (Issue 1150)
The FDA has approved the marketing of buprenorphine in sublingual tablets (Reckitt Benckiser) both alone (Subutex) and with naloxone (Suboxone) for treatment of opioid dependence. Previously available only...
The FDA has approved the marketing of buprenorphine in sublingual tablets (Reckitt Benckiser) both alone (Subutex) and with naloxone (Suboxone) for treatment of opioid dependence. Previously available only for parenteral use in treatment of pain (Buprenex, and others), it offers an alternative to methadone (Dolophine, and others), which is now often abused (New York Times, February 9, 2003; page 1). As a schedule III narcotic, buprenorphine will be subject to fewer prescribing restrictions than a schedule II drug such as methadone (MJ Kreek and FJ Vocci, J Subst Abuse Treat 2002; 23:93).w1150a