Constipation News and Research

Latest Constipation News and Research

FDA waives NDA filing fee for Antares' Anturol NDA

Antares Pharma, Inc. today announced the receipt from the U.S. Food and Drug Administration (FDA) of a waiver, on February 8, 2011, for the $1,500,000 New Drug Application (NDA) filing fee for Anturol® Gel for overactive bladder (OAB).

14 Feb 2011

Valeant Pharmaceuticals subsidiary acquires Canadian rights to Cholestagel

Valeant Pharmaceuticals International, Inc. today announced that its subsidiary, Biovail Laboratories International SRL, has acquired the Canadian rights to Cholestagel (colesevelam), an oral bile acid sequestrant for hypercholesterolemia, from Genzyme Corporation.

10 Feb 2011

Mallinckrodt receives FDA approval for Fentanyl Transdermal System patch ANDA

Covidien, a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for its Fentanyl Transdermal System (FTS) patch. Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.

10 Feb 2011

AMAG receives Health Canada Notice of Non-Compliance for Feraheme NDS

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it has received a Notice of Non-Compliance (NON) from Health Canada regarding its New Drug Submission (NDS) for Feraheme® (ferumoxytol) injection for intravenous (IV) use for the treatment of iron deficiency anemia in adult chronic kidney disease patients.

9 Feb 2011

Genentech's OCEANS Phase III study of Avastin in platinum-sensitive ovarian cancer meets primary endpoint

Genentech, a member of the Roche Group, announced today that OCEANS, a Phase III study evaluating Avastin® (bevacizumab) in combination with chemotherapy (carboplatin and gemcitabine) followed by continued use of Avastin alone until disease progression in women with previously treated (recurrent), platinum-sensitive ovarian cancer, met its primary endpoint.

8 Feb 2011

Progenics, Salix enter exclusive worldwide license agreement for RELISTOR

Progenics Pharmaceuticals, Inc. and Salix Pharmaceuticals, Ltd. today announced that they have entered into an exclusive worldwide (except Japan) agreement by which Salix has licensed rights to RELISTOR® (methylnaltrexone bromide).

7 Feb 2011

Phase II results of VELCADE in patients with aggressive lymphoma published in Journal of Clinical Oncology

Millennium: The Takeda Oncology Company today announced that Phase II results of a clinical trial examining VELCADE (bortezomib) in patients with previously untreated aggressive lymphoma were published in the Journal of Clinical Oncology.

5 Feb 2011

Study finds increased prescription drug abuse among teens

Illicit drugs like marijuana, cocaine and heroin have always been a parent's nightmare. But perfectly legal and easily accessible prescription medications are now the recreational drugs of choice for many teenagers, prompting physicians at Johns Hopkins Children's Center to urge pediatricians to screen specifically for their abuse during routine visits.

4 Feb 2011

Enrollment stopped in one of two global necitumumab Phase III studies in NSCLC

Eli Lilly and Company and Bristol-Myers Squibb Company announced today that they have stopped enrollment in one of their two global Phase III studies evaluating necitumumab, an investigational anti-cancer agent, as a first-line treatment for advanced non-small cell lung cancer (NSCLC).

3 Feb 2011

Phase III study shows tapentadol ER relieves chronic pain associated with DPN

New research has been published indicating that patients suffering from a painful complication of diabetes may experience a significant improvement in their pain as measured by a pain intensity scale when using an investigational pain medication.

29 Jan 2011

PediatRx announces first-ever revenues and successful launch of GRANISOL

PediatRx Inc.is pleased to provide an update on activities for the fiscal third quarter. Among its achievements, the hospital specialty pharmaceutical company reported its first-ever revenues and successfully launched GRANISOL™, the company's first commercial entry.

24 Jan 2011

Health Canada approves Labopharm's OLEPTRO for treatment of Major Depressive Disorder

Labopharm Inc. today announced that Health Canada's Therapeutic Products Directorate (TPD) has approved OLEPTRO, a novel once-daily formulation of the antidepressant trazodone, for the symptomatic relief of Major Depressive Disorder in adults.

21 Jan 2011

Forest Laboratories third quarter net sales increase 6.7% to $1,063.9 million

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer, announced that reported earnings per share equaled $1.11 in the third quarter of fiscal 2011 after taking a charge for a new product licensing fee of $66.1 million or $0.23 per share, net of tax.

18 Jan 2011

Cadence launches OFIRMEV pain medication in the U.S.

Cadence Pharmaceuticals, Inc. today announced the launch of OFIRMEV™ (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. The U.S. Food and Drug Administration (FDA) approved OFIRMEV in November 2010 for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

18 Jan 2011

PecFent accepted in Scotland for treatment of breakthrough cancer pain

Archimedes Pharma Ltd., a leading international specialty pharma company, today announced the decision by the Scottish Medicines Consortium to accept PecFent for use within NHS Scotland. PecFent is indicated for the treatment of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain.

18 Jan 2011

Adjunctive lacosamide reduces seizures and improves responder rates

Comprehensive analyses of pooled data from three randomized, double-blind, placebo-controlled Phase II/III trials showing the efficacy and tolerability of Vimpat® (lacosamide) C-V for patients with partial-onset seizures, regardless of the type of concomitant AED used, have been published in the drug evaluation journal, CNS Drugs.

13 Jan 2011

FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Merck today announced that the New Drug Application (NDA) for the Company's investigational extended-release formulation of JANUMET for type 2 diabetes has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is also moving forward as planned with regulatory filings in countries outside the United States.

12 Jan 2011

Shionogi brings KAPVAY ADHD drug to the U.S market

Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced a true milestone as it marks the first commercial availability for the non-central nervous system stimulant medication KAPVAY™, an extended-release oral formulation of clonidine for Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.

10 Jan 2011

Adolor initiates second ADL5945 Phase 2 study in opioid-induced constipation

Adolor Corporation today announced that it is initiating a second Phase 2 study of ADL5945 in chronic non-cancer pain patients suffering from opioid-induced constipation (OIC).

10 Jan 2011

FDA approves Abstral drug for treatment of breakthrough pain in cancer patients

Orexo AB announces today that its partner ProStrakan Group plc has received approval from the US Food and Drug Administration for Abstral. Abstral is licensed for the treatment of breakthrough pain in cancer patients, 18 years of age and older, who are already receiving, and are tolerant to, opioid analgesics for their underlying persistent cancer pain.

10 Jan 2011