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Hydromorphone in Medical News

CombinatoRx and Neuromed Sign Merger Agreement

...y capabilities. The rights to Exalgo(TM), designed to be a once-daily, oral hydromorphone treatment seeking FDA approval for chronic to severe pain, were recently ac...ts lead product candidate, Exalgo(TM) is an extended release formulation of hydromorphone in phase 3 clinical development. Neuromed is also developing oral drug cand...

FDA Warns Drug Makers to Stop Selling Unapproved Prescription Painkillers

... selling these unapproved drugs, including high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. Oxycodone capsules and approved tablets are not included in this warning, the agency noted. "The FDA wants to assure consumers who re...

Neuromed Announces Exalgo(TM) (hydromorphone HCl) Extended-Release Tablets (CII) Meets Primary Efficacy Endpoint in Pivotal Phase 3 Trial

... an extended release formulation of hydromorphone. hydromorphone is a Schedule II opioid that has been used for many years. Oral hydromorphone products currently available in the U.S. are immed...LL(TM) osmotic delivery system designed to release hydromorphone at a controlled rate over an extended period of ti...

Pharmacyclics Announces Dr. Ahmed Hamdy as New Chief Medical Officer

... From September 2004 to February 2006, Dr. Hamdy was a medical director at Johnson and Johnson/ALZA where he participated in NDA submissions for OROS hydromorphone (Jurnista(R)) for moderate to severe pain approved in Europe 2006. From October 2000 to August 2004, Dr. Hamdy was a Senior Principal Scientist at Wa...

Neuromed Completes Enrollment for Phase 3 Chronic Low Back Pain Clinical Trial of NMED-1077

...r. "If approved, this will be the only long-acting hydromorphone available in the U.S. market with a single dose pr...rial will be needed to support approval of OROS(R) hydromorphone in the U.S., Neuromed is conducting a second pivot... an extended release formulation of hydromorphone. hydromorphone is a Schedule II opioid that has been widely used ...

Cephalon Announces FDA Advisory Committee Recommendation Against Approval of an Expanded Label for FENTORA

...sting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid daily for a week or longer. FENTORA is not indicated for use in opioid non-tolerant patients inclu...

Polyanalgesic Consensus Panel's New Treatment Guidelines Via Intraspinal Infusion for Severe Chronic Pain

...vere chronic pain. The updated algorithm includes PRIALT (Elan Corp.) as a first-line alternative for intraspinal infusion to the opioids morphine and hydromorphone "We did an extensive review of the literature that has been performed and the consensus was the data was very supportive that PRIALT should be consid...

Neuromed Concludes a Special Protocol Assessment (SPA) with FDA for a Pivotal Phase 3 Study on NMED-1077

...her Gallen, Neuromed's President & CEO. "We believe a once-daily version of hydromorphone can be a significant benefit for patients with moderate to severe pain who ... also available from various generic manufacturers. Current formulations of hydromorphone marketed in the U.S. are immediate release, requiring dosing several times ...

Patient Safety Authority Releases Advisory Focusing on Common Causes of Medication Errors

...ke generic drug names: morphine and hydromorphone. hydromorphone is a common alternative to morphine for treating p...The potency difference in each is as follows: Oral hydromorphone is approximately four times more potent than oral ...re potent than injectable morphine; and injectable hydromorphone is approximately 20 times more potent than oral mo...
Hydromorphone in Medical Technology

Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain

...are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. Because life-threatening respiratory depression could occur at any dose in opio...

Cephalon Presents Positive Results for Fentora in Breakthrough Pain Associated with Neuropathic Conditions

...king at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. Because life-threatening respiratory depression could occur at any dose...
Hydromorphone in Biological Technology

ETHEX Corporation Issues Nationwide Voluntary Recall of Products

... Products Recalled to RETAIL PHARMACY Level: hydromorphone HCl Tablets, 2mg (58177-620-04 & 620-11) hydromorphone HCl Tablets, 4mg (58177-621-04 & 621-11) hydromorphone HCl Tablets, 8mg (58177-449-04) Metoprolol Suc...

IntelliPharmaCeutics Announces Successful Completion of a Pilot Clinical Trial for its Abuse and Alcohol Resistant Sustained Release Oxycodone

...so designed to resist release of the entire daily dose when consumed with alcohol in any quantity, a problem so serious with some opioid drugs such as hydromorphone that their use has been limited or curtailed by the FDA. The product has been subjected to rigorous in-vitro testing and has met its design criteria...

Cephalon Submits Supplemental New Drug Application for FENTORA

...are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. Because life-threatening respiratory depression could occur at any dose in opio...

Cephalon Reinforces Important Prescribing and Dosing Information for FENTORA

...are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. Because life-threatening respiratory depression could occur at any dose in opio...

Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain

...are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. Because life-threatening respiratory depression could occur at any dose in opio...
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