Content about Opioid

April 3, 2014

The Food and Drug Administration on Thursday approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet. 

March 28, 2014

Pharmacists in New Mexico have become the first in the United States certified to prescribe Narcan (naloxone), which prevents or reverses the effects of opioids including respiratory depression, sedation and hypotension, according to a report published Wednesday by The New Mexican.

SANTA FE, N.M. — Pharmacists in New Mexico have become the first in the United States certified to prescribe Narcan (naloxone), which prevents or reverses the effects of opioids including respiratory depression, sedation and hypotension, according to a report published Wednesday by The New Mexican

March 20, 2014

Purdue Pharma recently announced that a Phase 3 study of an investigational extended‐release formulation of hydrocodone bitartrate met its primary efficacy endpoint by showing that patients with chronic low back pain treated with the once‐daily analgesic agent experienced statistically significant reduction in pain compared with placebo.

STAMFORD, Conn. — Purdue Pharma recently announced that a Phase 3 study of an investigational extended‐release formulation of hydrocodone bitartrate met its primary efficacy endpoint by showing that patients with chronic low back pain treated with the once‐daily analgesic agent experienced statistically significant reduction in pain compared with placebo. 

March 18, 2014

Mallinckrodt Plc last week announced that the Food and Drug Administration approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), for the management of acute pain severe enough that it requires opioid treatment.

DUBLIN — Mallinckrodt Plc last week announced that the Food and Drug Administration approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), for the management of acute pain severe enough that it requires opioid treatment.

The drug also is indicated for patients for whom alternative treatments have shown to be ineffective. Xartemis XR, previously known as MNK-795, is the first and only extended-release oral combination of two clinically proven pain medications — oxycodone and acetaminophen.

March 14, 2014

In observance of National Poison Prevention Week, which is March 16 to 22, the National Safety Council has released a list of facts many people do not — but need to — know about prescription painkiller use.

ITASCA, Ill. — In observance of National Poison Prevention Week, which is March 16 to 22, the National Safety Council has released a list of facts many people do not — but need to — know about prescription painkiller use.

Did you know?

1. Forty-five people die every day from opioid prescription painkillers — more deaths than heroin and cocaine overdoses combined;

2. In 2010, enough prescription painkillers were provided to medicate every American around the clock for an entire month;

March 5, 2014

Most people who abuse prescription opioid drugs get them for free from a friend or relative — but those at highest risk of overdose are as likely to get them from a doctor’s prescription, Centers for Disease Control researchers reported Monday in a research letter, “Sources of Prescription Opioid Pain Relievers by Frequency of Past-Year Nonmedical Use: United States, 2008-2011,” in the Journal of the American Medical Association Internal Medicine.

ATLANTA — Most people who abuse prescription opioid drugs get them for free from a friend or relative — but those at highest risk of overdose are as likely to get them from a doctor’s prescription, Centers for Disease Control researchers reported Monday in a research letter, “Sources of Prescription Opioid Pain Relievers by Frequency of Past-Year Nonmedical Use: United States, 2008-2011,” in the Journal of the American Medical Association Internal Medicine.

February 24, 2014

Concurrent opioid prescribing by multiple providers is common in Medicare patients and is associated with higher rates of hospital admission related to opioid use, according to a study published last week in BMJ.

LONDON — Concurrent opioid prescribing by multiple providers is common in Medicare patients and is associated with higher rates of hospital admission related to opioid use, according to a study published last week in BMJ

December 2, 2013

Shionogi and Egalet have entered a deal worth up to $425 million for the development of abuse-deterrent opioid painkillers, Egalet said.

MALVERN, Pa. — Shionogi and Egalet have entered a deal worth up to $425 million for the development of abuse-deterrent opioid painkillers, Egalet said.

The deal centers on the development and potential commercialization of experimental drugs containing the opioid painkiller hydrocodone.

November 26, 2013

The Food and Drug Administration has accepted Purdue Pharma's regulatory approval application for a new opioid drug, Purdue said Tuesday.

STAMFORD, Conn. — The Food and Drug Administration has accepted Purdue Pharma's regulatory approval application for a new opioid drug, Purdue said Tuesday.

The drug maker announced the FDA's acceptance of its application for Targiniq (oxycodone hydrochloride; naloxone hydrochloride) controlled-release tablets. The drug combines oxycodone with the opioid agonist nalxone.

November 26, 2013

QRxPharma has resubmitted its regulatory approval application for an opioid painkiller for which it has sought Food and Drug Administration approval since 2011, the company said Tuesday.

BEDMINSTER, N.J. — QRxPharma has resubmitted its regulatory approval application for an opioid painkiller for which it has sought Food and Drug Administration approval since 2011, the company said Tuesday.

The Australian drug maker announced the resubmission of its application for Moxduo, a pill that combines oxycodone and morphine.The FDA is expected to schedule an advisory committee meeting to review the application for May 2014.

October 28, 2013

Depomed has launched a new drug for breakthrough pain in cancer patients, the company said Monday.

NEWARK, Calif. — Depomed has launched a new drug for breakthrough pain in cancer patients, the company said Monday.

The drug maker announced the launch of Lazanda (fentanyl) nasal spray, meant for treating adults who are taking opioid painkillers, but have become tolerant to them. The company also have launched a Signature Support Program designed to streamline patient access to the drug, including reimbursement and co-pay assistance. Other benefits of the program include prescription reminders and eligibility for one month's supply for free.

October 25, 2013

The Food and Drug Administration has approved a new opioid painkiller made by Zogenix, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new opioid painkiller made by Zogenix, the agency said Friday.

The FDA announced the approval of Zohydro ER (hydrocodone) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term treatment. The agency said the drug was the first extended-release hydrocodone product not combined with another drug, such as acetaminophen, to be approved by the agency.

October 25, 2013

The Food and Drug Administration plans to recommend stronger regulations for a commonly used opioid painkiller.

SILVER SPRING, Md. — The Food and Drug Administration plans to recommend stronger regulations for a commonly used opioid painkiller.

October 25, 2013

The Food and Drug Administration plans to officially recommend that products containing 15 mg or less of the opioid painkiller hydrocodone be rescheduled as Schedule II controlled substances, from the current Schedule III classification. While the idea is to combat abuse and misuse of the drugs, pharmacy groups say the rescheduling would make them harder to obtain for patients who legitimately need them.

The desire to combat abuse and misuse of prescription drugs — now a worse problem in the United States than cocaine or heroin — is laudable, but unlike those two drugs, hydrocodone has a legitimate use as a painkiller, and it's the people who are using it properly and legally who will end up losing.

The Food and Drug Administration plans to officially recommend that products containing 15 mg or less of the opioid painkiller hydrocodone be rescheduled as Schedule II controlled substances, from the current Schedule III classification. While the idea is to combat abuse and misuse of the drugs, pharmacy groups say the rescheduling would make them harder to obtain for patients who legitimately need them.

October 15, 2013

Actavis is hoping to become the first to market a generic version of a drug used to treat patients who have become dependent on opioid drugs, triggering a lawsuit from the branded drug's manufacturer.

DUBLIN — Actavis is hoping to become the first to market a generic version of a drug used to treat patients who have become dependent on opioid drugs, triggering a lawsuit from the branded drug's manufacturer.

The generic drug maker said it had filed a regulatory approval application with the Food and Drug Administration for buprenorphine hydrochloride and naloxone hydrochloride sublingual film in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The drug is a generic version of Reckitt Benckiser's Suboxone.

October 11, 2013

The global market for drugs to treat constipation resulting from use of opioid painkillers will increase more than tenfold by 2017, according to new research.

LONDON — The global market for drugs to treat constipation resulting from use of opioid painkillers will increase more than tenfold by 2017, according to new research.

October 3, 2013

The Food and Drug Administration is requiring Johnson & Johnson to use long-lasting ink in the labeling and dosage strength of an opioid painkiller patch it markets in order to make it easier to see.

SILVER SPRING, Md. — The Food and Drug Administration is requiring Johnson & Johnson to use long-lasting ink in the labeling and dosage strength of an opioid painkiller patch it markets in order to make it easier to see.

September 24, 2013

The Food and Drug Administration has approved a new dosage strength for a chronic pain patch made by Purdue Pharma, the drug maker said Tuesday.

STAMFORD, Conn. — The Food and Drug Administration has approved a new dosage strength for a chronic pain patch made by Purdue Pharma, the drug maker said Tuesday.

Purdue announced the approval of the 15-microgram-per-hour strength of Butrans (buprenorphine). The drug is used to treat moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The new strength is in addition to the 5-microgram, 10-microgram and 20-microgram strengths already on the market, and it will be launched next month.

September 16, 2013

A drug for treating opioid dependence has been launched, the manufacturer said Monday.

NEW YORK — A drug for treating opioid dependence has been launched, the manufacturer said Monday.

Orexo announced the introduction of Zubsolv (buprenorphine; naloxone) sublingual tablets for the maintenance treatment of opioid dependence. The drug is designed for use as part of a broader treatment regimen that combines drug therapy and counseling.

September 13, 2013

Companies that make long-acting opioid painkillers will be required to conduct studies to assess their safety, while use of the drugs will be restricted, under new requirements from the Food and Drug Administration.

SILVER SPRING, Md. — Companies that make long-acting opioid painkillers will be required to conduct studies to assess their safety, while use of the drugs will be restricted, under new requirements from the Food and Drug Administration.

The agency announced new labeling changes and regulatory requirements for makers of extended-release and long-acting opioids, citing the risk the drugs carry of overdose, abuse and withdrawal. In response, a group also cautioned consumers to be careful when using non-steroidal anti-inflammatory drugs.

September 3, 2013

A new opioid painkiller drug made by Upsher-Smith Labs will become available on Wednesday, the drug maker said.

MAPLE GROVE, Minn. — A new opioid painkiller drug made by Upsher-Smith Labs will become available on Wednesday, the drug maker said.

Upsher-Smith said it would launch its morphine sulfate extended-release capsules in the 10-mg, 20-mg, 30-mg, 50-mg, 60-mg, 80-mg and 100-mg strengths.

The company said its product would be the first generic entrant for the 10-mg extended-release capsule dosage strength, adding that there have historically been a limited number of morphine sulfate generics available.

 

July 17, 2013

New, abuse-deterrent formulations of two opioid painkillers have not necessarily reduced doctors' unease with prescribing them, according to a new study.

 BURLINGTON, Mass. — New, abuse-deterrent formulations of two opioid painkillers have not necessarily reduced doctors' unease with prescribing them, according to a new study.

July 9, 2013

The Food and Drug Administration has approved a new drug for treating opioid dependence.

NEW YORK — The Food and Drug Administration has approved a new drug for treating opioid dependence.

Orexo U.S. announced the approval of Zubsolv (buprenorphine; naloxone) sublingual tablets. The drug, Schedule III controlled substance, is approved for use once per day in the maintenance treatment of opioid dependence. Opioid dependence affects nearly 5 million people in the United States, according to the Substance Abuse and Mental Health Services Administration, but about 60% of those affected don't receive treatment.

July 8, 2013

Nearly 30 children have been accidentally poisoned by opioid painkiller patches since 1997, according to the Food and Drug Administration, prompting the agency to issue disposal guidelines.

NEW YORK — Nearly 30 children have been accidentally poisoned by opioid painkiller patches since 1997, according to the Food and Drug Administration, prompting the agency to issue disposal guidelines.

The FDA listed the guidelines on its website, saying that unused fentanyl patches should be stored out of the reach and sight of children, while used patches should be folded, sticky sides together, and flushed down the toilet.

July 2, 2013

A dramatic increase in the number of women dying from opioid painkiller overdoses has health officials alarmed.

NEW YORK — A dramatic increase in the number of women dying from opioid painkiller overdoses has health officials alarmed.

The Centers for Disease Control and Prevention announced Tuesday results of an analysis showing that nearly 48,000 women died of prescription painkiller overdoses between 1999 and 2010, with the rate of women dying this way in 2010 increasing more than five-fold during that time. The number of men who died from prescription painkiller overdoses in 2010 increased by 265% over 1999.