Metoclopramide News and Research

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No legal recourse because generic drug caused injury

Carrie Scott went in to the hospital for abnormal bleeding. Days later she returned home without her hand and forearm. The generic form of Phenergan was given improperly, apparently from an inadequate warning label. Scott has no legal recourse because a generic drug caused her injury, rather than its brand-name equivalent.

22 Jun 2012

Positive results from Acacia Phase II APD421 study in prevention of post-operative nausea & vomiting

Acacia Pharma announces positive results from its Phase II study of APD421, in the prevention of post-operative nausea & vomiting (PONV).

28 May 2012

Salix first quarter total product revenue increases 62% to $171.1M

Salix Pharmaceuticals, Ltd. today announced financial and operating results for the first quarter ended March 31, 2012 and other business updates.

8 May 2012

Greater patient and healthcare provider dialogue needed for morning sickness

Nausea and vomiting in pregnancy (NVP) is the most common medical condition in pregnancy, affecting an estimated 70 to 85% of all pregnant women. Yet in a recent national survey of more than 350 nurse practitioners (NPs), only 40% of their patients reported experiencing NVP in the last 12 months, pointing to the need for greater patient and healthcare provider dialogue about the condition.

27 Feb 2012

Salix third quarter total product revenue increases 81% to $146.2 million

Salix Pharmaceuticals, Ltd. today announced financial and operating results for the third quarter ended September 30, 2011 and other business updates.

9 Nov 2011

FDA accepts Salix and Progenics' sNDA filing for RELISTOR to treat opioid-induced constipation

Progenics Pharmaceuticals, Inc. and Salix Pharmaceuticals, Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental New Drug Application (sNDA) for RELISTOR Subcutaneous Injection to treat opioid-induced constipation (OIC) in patients with non-cancer pain.

30 Aug 2011

U.S. Supreme Court ruling on generic drugs

According to the new ruling from the U.S. Supreme Court, people harmed by generic drugs may find it harder to get restitution. The court ruled on Thursday that generic drug makers cannot be sued for failing to warn consumers of their products' side effects if they copy the exact warnings on the drugs' brand-name equivalents.

23 Jun 2011

Supreme Court ruling would affect around 10,000 Reglan-metoclopramide lawsuits

The U.S. Supreme Court is expected to rule shortly on whether generic drug companies must adequately warn doctors about new or revised risks to patients who have taken the drugs they make. (Pliva v Mensing No. 09-993, Actavis v Mensing No.08-3850 and Actavis v Demahy No. 09-1501) All three cases involve patients who took metoclopramide, the generic version of the brand-name drug Reglan.

20 Jun 2011

Phase 3 open-label study of RELISTOR presented at American Pain Society meeting

Salix Pharmaceuticals, Ltd. today announced findings from two analyses of a Phase 3 open-label study of RELISTOR (methylnaltrexone bromide) presented at the 30th Annual Scientific Meeting of the American Pain Society. The meeting is being held in Austin, TX, on May 19-21, 2011.

21 May 2011

Salix Pharmaceuticals receives three U.S. patents relating to rifaximin

Salix Pharmaceuticals, Ltd. today announced that the U.S. Patent and Trademark Office has issued three patents relating to rifaximin.

21 Apr 2011

Lupin grants Salix exclusive worldwide rights to rifaximin

Salix Pharmaceuticals, Ltd. today announced that as of March 31, 2011 Lupin Ltd. granted Salix exclusive worldwide rights (except for India) to exploit Lupin technology and technology jointly developed by Lupin and Salix for all rifaximin products for human use. This agreement expands the collaboration that Salix and Lupin entered into as of September 30, 2009.

6 Apr 2011

Salix anticipates receipt of FDA's CRL for XIFAXAN 550 mg sNDA

Salix Pharmaceuticals, Ltd. today announced that based on a telephone conversation with the U.S. Food and Drug Administration held last evening, the Company anticipates receiving a Complete Response Letter on or before the March 7, 2011 PDUFA goal date for the supplemental New Drug Application for XIFAXAN 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome and IBS-related bloating.

25 Feb 2011

Studies show XIFAXAN 550 mg tablets demonstrate significant relief of global IBS symptoms

Salix Pharmaceuticals, Ltd. today announced the New England Journal of Medicine has published results from TARGET 1 and TARGET 2, the Company's two pivotal Phase 3 efficacy and safety studies of XIFAXAN (rifaximin) 550 mg tablets for the treatment of Irritable Bowel Syndrome without constipation, or Non-C IBS.

6 Jan 2011

Salix to discuss XIFAXAN therapy for hepatic encephalopathy at AASLD 2010 Annual Meeting

Salix Pharmaceuticals, Inc. today announced that the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2010) will be an important venue for ongoing discussion of hepatic encephalopathy, or HE.

1 Nov 2010

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

Salix Pharmaceuticals, Ltd. today announced the presentation of two analyses of data from its Phase 3 pivotal clinical trials, TARGET 1 and 2, demonstrating a 14-day course of XIFAXAN 550 mg (rifaximin) taken three times daily achieved adequate relief of symptoms of non-constipation irritable bowel syndrome (non-C IBS) in a significantly greater proportion of patients compared with placebo.

19 Oct 2010

Masimo's noninvasive SpMet provides measurements comparable to invasive methemoglobin testing

Masimo announced today that a new clinical study published in Anesthesia & Analgesia demonstrates that Masimo noninvasive and continuous methemoglobin (SpMet®) measurements provide a high degree of agreement in measurements with corresponding laboratory values of methemoglobin obtained by invasive methemoglobin testing. In addition, the authors concluded that SpMet could facilitate early diagnosis and treatment of methemoglobinemia during high-risk procedures.

22 Sep 2010

FDA accepts Salix's XIFAXAN550 sNDA for Priority Review

Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Company's efficacy supplement to the New Drug Application (NDA) for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating.

9 Aug 2010

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Merck today announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent posaconazole for the treatment of chronic Chagas disease. Chagas disease results from infection with the parasite Trypanosoma cruzi that is spread by biting insects. The disease is estimated to affect approximately eight million people in Latin America, of whom approximately 30-40 percent will develop serious cardiac disease, digestive disease, or both as a result of this infection.

24 Jun 2010

Salix submits efficacy supplement for XIFAXAN NDA for Non-C IBS and IBS-related bloating

Salix Pharmaceuticals, Ltd. today announced that the Company has submitted an efficacy supplement to NDA 21-361 for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating.

8 Jun 2010

Salix Pharmaceuticals announces availability of Xifaxan tablets for reducing risk of overt HE recurrence

Salix Pharmaceuticals, Ltd. today announced the availability of Xifaxan (rifaximin) 550 mg tablets for the reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. Those HE patients may now fill their Xifaxan 550 mg prescriptions in U.S. pharmacies and should speak with their doctors about this important treatment option.

24 May 2010