Content about Morphinans

May 17, 2013

FDA advisory committee to meet in July on opioid painkiller

A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.

SYDNEY — A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.

Australia-based QRxPharma said the FDA had determined that an advisory committee would meet on July 17 to consider a resubmitted application for Moxduo, an immediate-release formulation of the opioid painkillers morphine and oxycodone.

May 13, 2013

FDA ruling on opioid painkiller deals blow to Endo

A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

SILVER SPRING, Md. — A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

May 9, 2013

OxyContin patent expires, fears of abuse return

The November 2011 expiration of Pfizer's patent on the cholesterol drug Lipitor and Ranbaxy Labs' release of the generic version received significant play in the media, particularly due to the theretofore status of Lipitor (atorvastatin calcium) as the drug with the highest sales in the country, $7.7 billion in the United States, according to healthcare analytics firm IMS Health.

April 26, 2013

Actavis can launch generic OxyContin in January 2014 under settlement with Purdue

Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said, saying it expected to make more than $100 million in the deal between 2014 and 2015.

PARSIPPANY, N.J. — Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said Friday, saying it expected to make more than $100 million in the deal between 2014 and 2015.

April 24, 2013

FDA approves drug for opioid-induced constipation

The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.

BETHESDA, Md. — The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.

April 19, 2013

CHPA's Stop Medicine Abuse campaign named honoree for the 17th Annual Webby Awards

The Consumer Healthcare Products Association’s Stop Medicine Abuse campaign was selected as an official honoree in the 17th Annual Webby Awards in the Family/Parenting category, the over-the-counter association announced.

WASHINGTON — The Consumer Healthcare Products Association’s Stop Medicine Abuse campaign was selected as an official honoree in the 17th Annual Webby Awards in the Family/Parenting category, the over-the-counter association announced Thursday.

April 16, 2013

Authorities worry about abuse potential as OxyContin patent expires

Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.

NEW YORK — Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.

April 16, 2013

FDA approves new labeling for OxyContin

The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said Tuesday.

The FDA announced that it approved updated labeling for reformulated OxyContin (oxycodone) extended-release tablets indicating that it has physical and chemical properties designed to deter drug abusers from crushing or dissolving the pills in order to inject or snort them.

April 9, 2013

Americans consider addiction a greater problem than chronic pain, poll shows

A majority of Americans say chronic pain ranks far below drug addiction as a major health problem, according to a new poll.

ALEXANDRIA, Va. — A majority of Americans say chronic pain ranks far below drug addiction as a major health problem, according to a new poll.

April 8, 2013

Teva introduces generic painkiller

Teva Pharmaceutical Industries has launched a generic opioid medication for treating pain, the company said.

NORTH WALES, Pa. — Teva Pharmaceutical Industries has launched a generic opioid medication for treating pain, the company said.

Teva announced the introduction of oxymorphone hydrochloride tablets.

The drug is a generic version of Endo Pharmaceuticals' Opana and will be available in the 5 mg and 10 mg strengths in bottles of 100 tablets.

March 26, 2013

FDA approves Actavis drug for opioid dependence

The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

Actavis announced the approval of buprenorphine hydrochloride and naloxone hydrochloride dehydrate sub-lingual tablets in the 2 mg/0.5 mg and 8 mg/2 mg strengths.

The drug is a generic version of Reckitt Benckiser's Suboxone, which had sales of about $625 million in 2012, according to IMS Health.

March 26, 2013

NCPA among industry associations rejecting proposal to reschedule hydrocodone

The National Community Pharmacists Association called for the rejection of a proposal made by Sens. Joe Manchin, D-W.Va., and Mark Kirk, R.-Ill., to reschedule Vicodin and other hydrocodone-containing products from Schedule III to Schedule II of the Controlled Substances Act.

ALEXANDRIA, Va. — The National Community Pharmacists Association last week called for the rejection of a proposal made by Sens. Joe Manchin, D-W.Va., and Mark Kirk, R.-Ill., to reschedule Vicodin and other hydrocodone-containing products from Schedule III to Schedule II of the Controlled Substances Act.

March 22, 2013

Senators introduce bill restricting sale of DXM cough-relieving ingredient to adults

Sens. Bob Casey, D-Pa., and Lisa Murkowski, R-Ark., on Friday introduced the Preventing Abuse of Cough Treatments Act of 2013, which would require retailers to restrict the sale of dextromethorphan-containing products to adults.

WASHINGTON — Sens. Bob Casey, D-Pa., and Lisa Murkowski, R-Ark., on Friday introduced the Preventing Abuse of Cough Treatments Act of 2013, which would require retailers to restrict the sale of dextromethorphan-containing products to adults. The bill also would restrict the sale of raw, bulk DXM to FDA-approved entities.

Many retailers have age restrictions on the sale of DXM products already in place; and similar legislation to this has been enforced in California since 2012.

March 14, 2013

FDA to review experimental opioid drug

The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

BEDMINSTER, N.J. — The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

Australia-based QRxPharma is seeking approval for Moxduo (morphine and oxycodone), and the FDA plans to decide whether to approve the drug on Aug. 26.

March 12, 2013

State, territorial attorneys general call for anti-tampering measures in opioids

The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

NEW YORK — The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

March 5, 2013

Amneal ships opioid-dependence drug

Amneal Pharmaceuticals has started shipping a drug used to treat opioid dependence, the company said Tuesday.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has started shipping a drug used to treat opioid dependence, the company said Tuesday.

The generic drug maker announced the shipment of buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablets in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The Food and Drug Administration approved the drug in February.

The drug includes a risk evaluation and mitigation strategy, or REMS, a program required by the FDA to ensure that its benefits outweigh its risks.

February 25, 2013

FDA approves Amneal opioid-dependence drug

Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

Amneal announced Monday the approval of buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, a generic version of Reckitt Benckiser Healthcare's Suboxone.

Suboxone had sales of $1.5 billion in 2012, according to IMS Health.

February 14, 2013

Actavis can launch generic painkiller in May 2014 under settlement

Actavis and Mallinckrodt have reached a settlement concerning the former's generic version of an opioid painkiller made by the latter, Actavis said Thursday.

PARSIPPANY, N.J. — Actavis and Mallinckrodt have reached a settlement concerning the former's generic version of an opioid painkiller made by the latter, Actavis said Thursday.

The companies settled patent lawsuit regarding Actavis' generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride) extended-release tablets in the 32-mg strength. The companies settled litigation regarding the 8-mg, 12-mg and 16-mg strengths last month.

February 5, 2013

NCPA to FDA: Rescheduling hydrocodone combo products to create headache for legitimate pain patients

The National Community Pharmacists Association submitted comments to the Food and Drug Administration urging the agency to preserve access to hydrocodone-containing pain relief products, as FDA considers moving the medications from the Drug Enforcement Administration’s Schedule III list of controlled substances to the more restrictive Schedule II list.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Monday submitted comments to the Food and Drug Administration urging the agency to preserve access to hydrocodone-containing pain relief products, as FDA considers moving the medications from the Drug Enforcement Administration’s Schedule III list of controlled substances to the more restrictive Schedule II list.

February 1, 2013

Study finds men on long-acting opioids have lower testosterone

Men taking long-acting medications for chronic pain are almost five times more likely to have low testosterone levels, according to a new study by Kaiser Permanente.

OAKLAND, Calif. — Men taking long-acting medications for chronic pain are almost five times more likely to have low testosterone levels, according to a new study by Kaiser Permanente.

The study, which the healthcare system called the first to show a significant difference in risk between short-acting and long-acting opioids, appeared in The Clinical Journal of Pain.

January 23, 2013

Parents not very concerned about prescription narcotic misuse, poll finds

A new study indicated that some parents may not be sufficiently concerned about misuse of narcotic painkillers by children and teenagers.

ANN ARBOR, Mich. — A new study indicated that some parents may not be sufficiently concerned about misuse of narcotic painkillers by children and teenagers.

January 9, 2013

WEB FEATURE: FDA guidance aims to encourage abuse-deterrent painkillers

One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.

SILVER SPRING, Md. — One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.

December 27, 2012

Survey: DXM abuse among high school students holds steady at just under 5%

The National Institute on Drug Abuse last week released the 2012 Monitoring the Future survey, finding that 5.6% of high school seniors, 3% of eighth graders and 4.7% of tenth graders abused over-the-counter cough and cold medicines containing dextromethorphan, bringing the overall average to under 5%.

BETHESDA, Md. — The National Institute on Drug Abuse last week released the 2012 Monitoring the Future survey, finding that 5.6% of high school seniors abused over-the-counter cough and cold medicines containing dextromethorphan, a rate that has held relatively steady over the past five years. Abuse of DXM products was reported to be 3% among eighth graders and 4.7% among tenth graders, bringing the overall average to under 5%.

December 21, 2012

Federal court rules against Endo in painkiller case

A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.

CHADDS FORD, Pa. — A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.

The U.S. District Court for the District of Columbia dismissed a case filed by Endo subsidiary Endo Pharmaceuticals against the Food and Drug Administration, in which the company had argued that the FDA failed meet a legal obligation to determine whether the original formulation of Opana ER (oxymorphone) extended-release tablets was withdrawn from the market for safety reasons.

November 20, 2012

Reports: Canada to allow generic OxyContin approval over provincial, tribal objections

Canadian regulators have allowed the approval process for a generic opioid painkiller to go forward despite objections from provincial and other authorities, according to published reports.

NEW YORK — Canada's federal government has allowed the approval process for a generic opioid painkiller to go forward despite objections from provincial and other authorities, according to published reports.

The Associated Press reported that Canadian health minister Leona Aglukkaq turned down requests from provincial and aboriginal tribal authorities to delay approval of a generic version of Purdue Pharma's OxyContin (oxycodone). OxyContin will lose its patent protection in Canada on Sunday.