Content about Opioids

May 25, 2011

Mylan has launched a generic version of an opioid painkiller, the company said Wednesday.

PITTSBURGH — Mylan has launched a generic version of an opioid painkiller, the company said Wednesday.

Mylan announced the launch of oxycodone hydrochloride tablets in the 5-mg, 15-mg and 30-mg strengths. Mylan is launching the drug under a development and supply agreement with Coastal Pharmaceuticals.

The drug is a generic version of Xanodyne’s Roxicodone, a treatment for moderate to severe pain. Oxycodone hydrochloride tablets had sales of about $325 million during the 12-month period ended in March, according to IMS Health.

April 29, 2011

The number of unintentional deaths from overdosing on prescription opioid painkillers in 2007 was greater than those from heroin and cocaine combined, according to a new study by medical researchers at the University of North Carolina, Duke University and the Centers for Disease Control and Prevention, who in particular called such deaths among teenagers and adults a national epidemic.

CHAPEL HILL, N.C. — The number of unintentional deaths from overdosing on prescription opioid painkillers in 2007 was greater than those from heroin and cocaine combined, according to a new study by medical researchers at the University of North Carolina, Duke University and the Centers for Disease Control and Prevention, who in particular called such deaths among teenagers and adults a national epidemic.

April 20, 2011

The Obama administration is looking to curb the growing national epidemic of prescription painkiller abuse, according to a plan unveiled Tuesday.

WASHINGTON — The Obama administration is looking to curb the growing national epidemic of prescription painkiller abuse, according to a plan unveiled Tuesday.

Elements of the plan include expansion of state-based prescription drug monitoring programs, recommendation of convenient and environmentally responsible drug-disposal methods, education and reduction of doctor shopping.

April 11, 2011

Another generic drug maker is seeking to market its version of a popular opioid painkiller.

HAYWARD, Calif. — Another generic drug maker is seeking to market its version of a popular opioid painkiller.

Impax said it had filed applications with the Food and Drug Administration seeking approval for a generic version of Purdue Pharma’s Oxycontin (oxycodone) controlled-release tablets in the 10-, 15-, 20-, 30-, 40-, 60- and 80-mg strengths.

Purdue filed suit against Impax on April 8 in the U.S. District Courts for the Southern District of New York, seeking to prevent Impax from marketing its version before the expiration of Purdue's patents.

April 4, 2011

A drug used to treat pain in cancer patients now is available in the United States.

BEDMINSTER, N.J. — A drug used to treat pain in cancer patients now is available in the United States.

ProStrakan Group announced Monday the launch of Abstral (fentanyl) sublingual tablets. The tablets, which disintegrate rapidly and are placed under the tongue, treat breakthrough pain, common in one-half to two-thirds of people with cancer-related pain.

The drug, an opioid and controlled substance, only is available through a Food and Drug Administration-mandated REMS program. The FDA approved the drug in January.

March 30, 2011

Many patients with heart failure skip pills due to medication costs, according to research by the Mayo Clinic.

ROCHESTER, Minn. — Many patients with heart failure skip pills due to medication costs, according to research by the Mayo Clinic.

The study, published in the journal Mayo Clinic Proceedings, tracked the pharmacy records of 209 patients ages 60 to 86 years in Olmsted County, Minn., who were asked how often they missed doses or didn’t take their drugs at all and why.

March 25, 2011

A generic painkiller made by Watson Pharmaceuticals infringes a patent covering the branded version, a U.S. District Court ruled.

MORRISTOWN, N.J. — A generic painkiller made by Watson Pharmaceuticals infringes a patent covering the branded version, a U.S. District Court ruled.

Watson said Friday that the U.S. District Court for the District of Delaware decided that Watson’s generic version of Cephalon’s Fentora (fentanyl) buccal tablets infringes U.S. Patent No. 6,264,981, though the Food and Drug Administration had approved Watson’s version of the drug.

March 17, 2011

Anglo-Swedish drug maker AstraZeneca has enrolled the first patient in a late-stage clinical trial for a drug to treat constipation related to use of opioid painkillers, the company said.

WILMINGTON, Del. — Anglo-Swedish drug maker AstraZeneca has enrolled the first patient in a late-stage clinical trial for a drug to treat constipation related to use of opioid painkillers, the company said.

March 15, 2011

A generic painkiller made by Watson Pharmaceuticals does not infringe on the patent covering the branded version, a U.S. District Court has ruled.

MORRISTOWN, N.J. — A generic painkiller made by Watson Pharmaceuticals does not infringe on the patent covering the branded version, a U.S. District Court has ruled.

Watson said the U.S. District Court for the District of Delaware ruled that Watson’s generic version of Cephalon’s Fentora (fentanyl buccal tablets) does not infringe on two patents that were set to expire in March 2019, according to Food and Drug Administration records.

March 9, 2011

Drug maker Purdue Pharma is giving a $1 million grant to the state of Florida to help fund the state’s prescription drug monitoring program, the company said Wednesday.

STAMFORD, Conn. — Drug maker Purdue Pharma is giving a $1 million grant to the state of Florida to help fund the state’s prescription drug monitoring program, the company said Wednesday.

Purdue said the program was designed to combat illegal diversion and abuse of prescription drugs. Purdue is the maker of OxyContin (oxycodone), an extended-release opioid painkiller that often is a target of abuse.

February 14, 2011

The Food and Drug Administration has accepted for review an application for a pain medication designed to thwart drug abusers.

PALATINE, Ill. — The Food and Drug Administration has accepted for review an application for a pain medication designed to thwart drug abusers.

Acura Pharmaceuticals announced Monday the acceptance of King Pharmaceuticals’ application for Acurox (oxycodone hydrochloride). King developed the drug using Acura’s Aversion technology, which is designed to limit or impede the ability to abuse the drug by dissolving or crushing the pills and then injecting them.

February 11, 2011

The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

ST. LOUIS — The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

Mallinckrodt, part of Covidien, said the FDA approved its fentanyl transdermal system patch.

The patch is a generic version of Johnson & Johnson’s Duragesic. The drug, an opioid and Class II controlled substance, is used for managing persistent, moderate-to-severe pain that requires continuous opioid administration.

February 7, 2011

Salix Pharmaceuticals and Progenics Pharmaceuticals have entered a licensing agreement for a drug used to treat side effects of opioid use.

TARRYTOWN, N.Y. — Salix Pharmaceuticals and Progenics Pharmaceuticals have entered a licensing agreement for a drug used to treat side effects of opioid use.

The two companies signed the agreement for Relistor (methylnaltrexone bromide), an injected drug used to treat opioid-induced constipation in patients for whom laxatives haven’t worked.

January 28, 2011

A drug made by Johnson & Johnson may be effective in reducing pain in patients with a complication of diabetes, according to a late-stage clinical study.

RARITAN, N.J. — A drug made by Johnson & Johnson may be effective in reducing pain in patients with a complication of diabetes, according to a late-stage clinical study.

January 27, 2011

The Food and Drug Administration has accepted a regulatory approval application for a pain drug that it previously had declined to approve.

CUPERTINO, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a pain drug that it previously had declined to approve.

Durect announced Thursday that the FDA had accepted a resubmitted application by King Pharmaceuticals for Remoxy (oxycodone), a controlled-release painkiller designed to reduce the risks of misuse. King and Pain Therapeutics are developing the drug using Durect’s drug-delivery technology.

January 20, 2011

British drug maker ProStrakan Group will partner with two U.S. companies to administer its risk evaluation and mitigation strategy for a cancer pain drug.

ATLANTA — British drug maker ProStrakan Group will partner with two U.S. companies to administer its risk evaluation and mitigation strategy for a cancer pain drug.

ProStrakan said it would use RelayHealth Pharmacy Solutions’ and McKesson Specialty Care Solutions’ services to administer the REMS for Abstral (fentanyl citrate), a drug that patients can place under the tongue to treat breakthrough pain associated with cancer when they already have received and become tolerant of opioid painkillers.

January 10, 2011

The Food and Drug Administration has approved a new drug for treating pain in cancer patients, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating pain in cancer patients, the agency said Friday.

The FDA announced the approval of ProStrakan’s Abstral (fentanyl) transmucosal tablets for the management of pain that appears suddenly for short periods and is not alleviated by a patient’s normal pain-management plan, also known as breakthrough pain. The tablets are designed for administration on the soft surfaces of the mouth, including inside the cheek, gums and tongue, as well as the nasal passages or the throat.

January 10, 2011

The Food and Drug Administration declined to approve Endo Pharmaceuticals’ regulatory application for a painkiller designed to thwart drug abusers, Endo said Friday.

CHADDS FORD, Pa. — The Food and Drug Administration declined to approve Endo Pharmaceuticals’ regulatory application for a painkiller designed to thwart drug abusers, Endo said Friday.

January 10, 2011

The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related pain, Watson said Monday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related pain, Watson said Monday.

Watson announced the approval of fentanyl buccal tablets in the 0.1-mg, 0.2-mg, 0.6-mg and 0.8-mg strengths.

December 20, 2010

Drug makers King Pharmaceuticals and Acura Pharmaceuticals have submitted a regulatory approval application to the Food and Drug Administration for an opioid pain reliever.

BRISTOL, Tenn. — Drug makers King Pharmaceuticals and Acura Pharmaceuticals have submitted a regulatory approval application to the Food and Drug Administration for an opioid pain reliever.

The two drug makers announced Tuesday the submission for Acurox (oxycodone hydrochloride), an immediate-release tablet for relief of moderate to severe pain.

The tablets use Acura’s aversion technology, designed to deter abuse of the drug by dissolving or crushing the pills.

December 15, 2010

Drug maker Watson Pharmaceuticals said it has filed a regulatory approval application for a generic painkiller, challenging the patent that covers the branded version.

MORRISTOWN, N.J. — Drug maker Watson Pharmaceuticals said it has filed a regulatory approval application for a generic painkiller, challenging the patent that covers the branded version.

Watson announced Tuesday that it had filed an application with the Food and Drug Administration seeking approval for hydromorphone hydrochloride extended-release tablets in the 8-mg, 12-mg and 16-mg strengths. The drug is a generic version of Mallinckrodt’s Exalgo.

November 21, 2010

A drug maker will pull a common prescription painkiller from the market following the release...

SILVER SPRING, Md. A drug maker will pull a common prescription painkiller from the market following the release of clinical data that it could cause heart problems.

 

November 2, 2010

The value of the market for specialty injectable drugs will top $90 billion by 2014,...

November 1, 2010

Strong generic sales helped Endo edge analyst expectations for the third quarter, the company noted....

CHADDS FORD, Pa. Strong generic sales helped Endo edge analyst expectations for the third quarter, the company noted.

Net income reached $54.2 million, compared with $49.4 million during the period ended Sept. 30. Net sales jumped 23% to $444.1 million, versus $361 million during the same period a year ago. Analysts had estimated sales of $443.36 million for the quarter.

October 25, 2010

Actavis last week recalled 18 lots of its patches designed to treat persistent, moderate to...

MORRISTOWN, N.J. Actavis last week recalled 18 lots of its patches designed to treat persistent, moderate to severe chronic pain.