Content about Opioids

November 21, 2011

Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

HAYWARD, Calif. — Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

Impax said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Cephalon's Fentora (fentanyl) buccal tablets in the 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg strengths. The drug is used to treat breakthrough cancer pain, defined as pain related to cancer that can't be controlled by other drugs.

November 15, 2011

Actavis has launched an authorized generic drug for treating pain, the company said.

MORRISTOWN, N.J. — Actavis has launched an authorized generic drug for treating pain, the company said.

The drug maker announced Friday that it had started shipping morphine sulfate extended-release capsules, an authorized generic version of Kadian, which it also manufactures. The authorized generic product was launched on the same day as Watson Pharmaceuticals' generic version.

November 11, 2011

Watson Pharmaceuticals has launched its generic version of an opioid drug for treating pain, the company said Thursday.

PARSIPPANY, N.J. — Watson Pharmaceuticals has launched its generic version of an opioid drug for treating pain, the company said Thursday.

Watson announced the Food and Drug Administration approval and launch of morphine sulfate extended-release capsules.

The drug is a generic version of Actavis' Kadian, which had sales of about $275 million during the 12-month period ended in September, according to IMS Health.

November 8, 2011

Purdue Pharma has launched a new way for fighting pharmacy crime, the drug maker said Tuesday.

STAMFORD, Conn. — Purdue Pharma has launched a new way for fighting pharmacy crime, the drug maker said Tuesday.

October 31, 2011

A Johnson & Johnson subsidiary has sent a regulatory application to the Food and Drug Administration seeking approval for one of its drugs in treating diabetes-related pain.

TITUSVILLE, N.J. — A Johnson & Johnson subsidiary has sent a regulatory application to the Food and Drug Administration seeking approval for one of its drugs in treating diabetes-related pain.

October 27, 2011

Mylan has received final approval from the Food and Drug Administration for a drug designed to treat moderate to severe pain.

PITTSBURGH — Mylan has received final approval from the Food and Drug Administration for a drug designed to treat moderate to severe pain.

Mylan said its abbreviated new drug application for morphine sulfate extended-release tablets in the 15-mg, 30-mg, 60-mg, 100-mg and 200-mg strengths was approved by the FDA. The opioid analgesic is a generic version of Purdue Pharma's MS Contin. Mylan said it is launching the product immediately.

Morphine sulfate ER tablets had U.S. sales of approximately $173 million for the 12 months ended in June, according to IMS Health.

October 17, 2011

Archimedes Pharma has launched a new drug for breakthrough cancer pain, the drug maker said Monday.

BEDMINSTER, N.J. — Archimedes Pharma has launched a new drug for breakthrough cancer pain, the drug maker said Monday.

Archimedes announced the launch of Lazanda (fentanyl) nasal spray for adult patients who have developed a tolerance to opioid therapy for persistent, underlying cancer pain. The drug uses Archimedes' patented PecSys delivery system, which allows the drug to be absorbed across the nasal membrane and directly into the bloodstream. The Food and Drug Administration approved the drug on June 30.

October 10, 2011

The Federal Trade Commission has given Teva Pharmaceutical Industries the green light to acquire Frazer, Pa.-based drug maker Cephalon, but with some restrictions, Teva said.

JERUSALEM — The Federal Trade Commission has given Teva Pharmaceutical Industries the green light to acquire Frazer, Pa.-based drug maker Cephalon, but with some restrictions, Teva said.

Before it can complete the $6.8 billion deal, Teva must sell to Par Pharmaceutical Cos. its generic versions of two Cephalon drugs, namely generic versions of the cancer pain drug Actiq (fentanyl citrate) and the muscle relaxant drug Amrix (cyclobenzaprine), which have combined sales of $298 million per year, according to IMS Health.

October 7, 2011

Watson Pharmaceuticals is looking to become the first to market a generic version of a painkiller made by Pfizer, the drug maker said Friday.

PARSIPPANY, N.J. — Watson Pharmaceuticals is looking to become the first to market a generic version of a painkiller made by Pfizer, the drug maker said Friday.

Watson said it filed a regulatory approval application with the Food and Drug Administration for morphine sulfate and naltrexone hydrochloride extended-release capsules in the 30-mg/1.2-mg, 50-mg/2-mg, 60-mg/2.4-mg, 80-mg/3.2-mg and 100-mg/4-mg strengths. The drug is a generic version of Embeda, made by Pfizer subsidiary King Pharmaceuticals.

October 4, 2011

Amneal last month launched its version of an epilepsy treatment.

BRIDGEWATER, N.J. — Amneal last month launched its version of an epilepsy treatment.

The drug maker said that felbamate tablets are available in 400-mg and 600-mg strengths, following approval from the Food and Drug Administration last month. The drug is the first-to-market generic equivalent of Meda Pharmaceuticals' Felbatol, Amneal said.

The Amneal generic is available in 90-count bottles in 400-mg strength and 90- and 180-count sizes in 600-mg strength, the company said.

Annual U.S. sales of Felbatol totaled $43.7 million, according to IMS Health data.

September 9, 2011

The Food and Drug Administration has approved a generic drug made by Mylan for treating allergies.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan for treating allergies.

Mylan announced Friday the approval of promethazine hydrochloride tablets in the 12.5-mg, 25-mg and 50-mg strengths.

Promethazine hydrochloride tablets, which are manufactured by several companies, had sales of about $42 million during the 12-month period ended in June, according to IMS Health.

August 31, 2011

Lupin has received final approval from the Food and Drug Administration for a generic version of a drug designed to treat moderate to moderately severe chronic pain in adults who require around-the-clock treatment for an extended period of time.

BALTIMORE — Lupin has received final approval from the Food and Drug Administration for its version of a drug designed to treat moderate to moderately severe chronic pain in adults who require around-the-clock treatment for an extended period of time.

Lupin said that it received final approval for its abbreviated new drug application for tramadol hydrochloride extended-release tablets in the 100-mg, 200-mg and 300-mg strengths. The drug is a generic version of Ultram ER tablets, which is marketed by Johnson & Johnson subsidiary Ortho-McNeil-Janssen Pharmaceuticals.

August 30, 2011

The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

TARRYTOWN, N.Y. — The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

The two drug makers announced Tuesday that the FDA had accepted their supplemental new drug application for Relistor (methylnaltrexone bromide), an injectable drug for treating opioid-induced constipation.

August 26, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating chronic pain, a J&J subsidiary said Friday.

RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating chronic pain, a J&J subsidiary said Friday.

The FDA approved Janssen Pharmaceuticals' Nucynta ER (tapentadol) tablets, an extended-release drug for moderate to severe chronic pain in adults for whom a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

August 18, 2011

Johnson & Johnson has launched several new tools on a website aimed at ensuring patients with pain get the drugs they need while staying safe.

RARITAN, N.J. — Johnson & Johnson has launched several new tools on a website aimed at ensuring patients with pain get the drugs they need while staying safe.

J&J subsidiary Janssen Pharmaceuticals added resources and tools to PrescribeResponsibly.com for physicians and pharmacists to support appropriate and responsible treatment of pain. The site was originally launched early last year.

August 12, 2011

Lannett announced that it has started shipping morphine sulfate oral solution, a painkiller approved by the Food and Drug Administration in June.

PHILADELPHIA—Lannett has started shipping a painkiller product approved by the Food and Drug Administration in June, the company said.

Lannett announced the shipment of morphine sulfate oral solution. Lannett sought FDA approval using a 505(b)(2) new drug application. Sales of morphine sulfate oral solution at average wholesale price were $31.7 million during the 12-month period ending in June, according to Wolters Kluwer.

August 2, 2011

The Food and Drug Administration has approved an opioid painkiller made by Covidien's generic drug division, the medical supply company said.

ST. LOUIS — The Food and Drug Administration has approved an opioid painkiller made by Covidien's generic drug division, the medical supply company said.

Covidien said the FDA approved Mallinckrodt's morphine sulfate oral solution, used to relieve moderate to severe acute and chronic pain in opioid-tolerant patients.

July 21, 2011

The Food and Drug Administration has approved a risk evaluation and mitigation strategy for two painkillers made by Cephalon, the drug maker said Thursday.

FRAZER, Pa. — The Food and Drug Administration has approved a risk evaluation and mitigation strategy for two painkillers made by Cephalon, the drug maker said Thursday.

The FDA approved a REMS for Fentora (fentanyl) buccal tablets and Actiq (oral transmucosal fentanyl citrate). Both drugs are used for managing breakthrough pain in cancer patients who have become tolerant of opioid drugs.

July 20, 2011

Purdue Pharma has launched a new website designed to combat abuse of prescription drugs, the company said Wednesday.

STAMFORD, Conn. — Purdue Pharma has launched a new website designed to combat abuse of prescription drugs, the company said Wednesday.

The website, RxSafetyMatters.org, is designed to help healthcare professionals, police and community organizations combat prescription drug diversion and abuse. Purdue is the developer of OxyContin (oxycodone), an extended-release painkiller that is frequently a target of drug abusers.

July 18, 2011

Australian drug maker QRxPharma is seeking approval for a drug that combines two painkillers in one pill, the company said Monday.

SYDNEY — Australian drug maker QRxPharma is seeking approval for a drug that combines two painkillers in one pill, the company said Monday.

QRxPharma announced that it had filed a regulatory approval application with the Food and Drug Administration for MoxDuo IR (morphine and oxycodone). The drug is designed to release both drugs into the body immediately.

June 24, 2011

The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

CHADDS FORD, Pa. — The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

The agency had declined to approve Endo’s Opana ER (oxymorphone hydrochloride) in January for reasons that the company did not specify, though the agency did not request additional clinical studies in its statement, known as a complete response letter.

June 24, 2011

The Food and Drug Administration has declined to approve an investigative painkiller made by Pfizer, the drug maker said Friday.

NEW YORK — The Food and Drug Administration has declined to approve an investigative painkiller made by Pfizer, the drug maker said Friday.

The FDA issued a complete response letter for Remoxy (oxycodone) extended-release capsules, which Pfizer is developing under a partnership with Pain Therapeutics. Pain Therapeutics originally developed the drug using Durect’s Oradur technology, which is designed to prevent tampering by drug abusers, in collaboration with King Pharmaceuticals. Pfizer took control of development of the drug when it acquired King in February.

June 22, 2011

The Food and Drug Administration has approved a medication designed to treat acute and chronic moderate to severe pain, where the use of an opioid analgesic is suitable.

NEW YORK — The Food and Drug Administration has approved a medication designed to treat acute and chronic moderate to severe pain, where the use of an opioid analgesic is suitable.

Pfizer and Acura Pharmaceuticals said that their drug Oxecta (oxycodone HCl, USP tablets) is the first tamper-resistant medication designed to deter abuse and misuse with Aversion technology, which is being licensed by Pfizer from Acura.

June 7, 2011

Generic drug maker Lannett said that the Food and Drug Administration has assigned a Prescription Drug User Fee Act action date for one of Lannett's drugs.

PHILADELPHIA — Generic drug maker Lannett said that the Food and Drug Administration has assigned a Prescription Drug User Fee Act action date for one of Lannett's drugs.

The FDA said it revised its PDUFA goal date of June 23 for Lannett's new drug application for morphine sulfate oral solution.

"With a revised PDUFA date in 17 days, we are preparing for the relaunch of our morphine sulfate oral solution product, if approved,” Lannett president and CEO Arthur Bedrosian said.

May 26, 2011

Medication nonadherence is sort of similar to substance abuse: It’s a societal issue that stems from multiple causes and as such, probably will never completely disappear; however, it still can be mitigated. And because it stems from multiple causes, effectively combating it also requires multiple strategies.

WHAT IT MEANS AND WHY IT'S IMPORTANT — Medication nonadherence is sort of similar to substance abuse: It’s a societal issue that stems from multiple causes and as such, probably will never completely disappear; however, it still can be mitigated. And because it stems from multiple causes, effectively combating it also requires multiple strategies.