Hyponatremia News and Research

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Hyponatremia refers to an abnormally low level of the electrolyte sodium (salt) in the blood. Sodium is an electrolyte that helps regulate the amount of water within and around cells in the body.

Older adults with low sodium experience increased rates of fractures, falls: Study

Older adults with even mildly decreased levels of sodium in the blood (hyponatremia) experience increased rates of fractures and falls, according to a study presented at the American Society of Nephrology's 43rd Annual Meeting and Scientific Exposition. Falls are a serious health problem for the elderly and account for about 50 percent of deaths due to injury in the elderly.

20 Nov 2010

Biogen Idec and Cardiokine terminate lixivaptan collaboration

Biogen Idec and Cardiokine, Inc. today announced that they have agreed to dissolve their collaboration on lixivaptan. The termination of the collaboration, which began in 2007, triggers the return of all rights to lixivaptan to Cardiokine.

4 Nov 2010

FDA approves Gamunex-C for primary immunodeficiency treatment

Talecris Biotherapeutics announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI).

15 Oct 2010

Acetadote Injection is now commercially available in Australia

Cumberland Pharmaceuticals Inc. and Phebra Pty Ltd. today announced that Acetadote (acetylcysteine) Injection, an injectable product used to treat acetaminophen (paracetamol) overdose, is now commercially available in the Australian market. Phebra Pty Ltd., an Australian-based specialty pharmaceutical company, has an exclusive license from U.S.-based Cumberland Pharmaceuticals to market and distribute the product in Australia.

15 Oct 2010

Genentech initiates GDC-0449 Phase II clinical trial in BCC patients

Curis, Inc. a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that its collaborator Genentech, a member of the Roche Group, has initiated a Phase II clinical trial of GDC-0449, an orally-administered small molecule Hedgehog Pathway Inhibitor, as a single-agent therapy for patients with operable basal cell carcinoma (BCC).

11 Oct 2010

Hyponatremia may lead to neurological complications

A new study published in the October issue of the journal Hepatology found that patients with severe portal-hypertensive bleeding who are treated with terlipressin may experience an acute reduction of sodium in their blood. This reduction in serum sodium, known as hyponatremia, can cause adverse reactions such as neurological complications, and is rapidly reversible upon terlipressin withdrawal.

23 Sep 2010

FDA extends review on Acetadote for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. today announced the U.S. Food and Drug Administration (FDA) has extended its review of the supplemental new drug application (sNDA) for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure.

21 Aug 2010

Cumberland Pharmaceuticals reports 9% increase in second quarter 2010 net revenue

Cumberland Pharmaceuticals Inc. ,a specialty pharmaceutical company focused on the hospital acute care and gastroenterology markets, today announces financial results for the second quarter ending June 30, 2010, and provides revenue guidance for full year 2010.

17 Aug 2010

Labopharm launches antidepressant OLEPTRO for major depressive disorder in U.S.

Labopharm Inc. today announced that OLEPTRO(TM) (trazodone hydrochloride extended-release tablets), a novel once-daily formulation of the antidepressant trazodone, has been launched in the United States by its joint venture with Gruppo Angelini, Angelini Labopharm. OLEPTRO(TM) is indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of OLEPTRO(TM) has been established in a trial of outpatients with MDD as well as in trials with the immediate release formulation of trazodone.

11 Aug 2010

Curis announces preliminary results of GDC-0449 Phase II clinical trial in advanced ovarian cancer

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that it has received preliminary results from a Phase II clinical trial of GDC-0449 from Roche and Genentech, Curis' collaborator and a member of the Roche Group.

9 Aug 2010

Insights into complex interrelationships between heart and kidneys

Research is yielding new understanding of the interactions between the heart and the kidneys—particularly the cardiorenal syndrome, in which failure of either organ can lead to failure of the other. Recent insights into the complex interrelationships between the heart and kidneys are presented in a special symposium section of the July issue of The American Journal of Medical Sciences (AJMS), official journal of the Southern Society for Clinical Investigation.

7 Jul 2010

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.

25 Jun 2010

Curis reports topline results from GDC-0449 Phase II clinical trial for metastatic colorectal cancer

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced topline results from a Phase II clinical trial conducted by Roche and Genentech, Curis' collaborator and a wholly owned member of the Roche Group, of GDC-0449, a first-in-class Hedgehog pathway inhibitor. GDC-0449 was tested in combination with Avastin® (bevacizumab) and FOLFOX or FOLFIRI chemotherapy in first-line metastatic colorectal cancer patients.

17 Jun 2010

Water is essential but electrolyte drinks are needed when exercising in heat

Water is essential when exercising in the heat but it might not be enough to keep you healthy in Houston summers.

5 Jun 2010

Antiemetic-regimen with fosaprepitant injection provides similar protection against CINV as oral EMEND

Merck announced today results from a new non-inferiority trial of an antiemetic regimen containing fosaprepitant dimeglumine administered as a single intravenous (IV) 150-mg dose in combination with a 5-HT3 antagonist and dexamethasone compared with a three-day regimen of aprepitant with a 5-HT3 antagonist and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving a first cycle of cisplatin-based chemotherapy.

4 Jun 2010

Australian TGA approves Acetadote for treatment of paracetamol poisoning

Cumberland Pharmaceuticals Inc. and Phebra Pty Ltd. today announced that Acetadote® (acetylcysteine) Injection has been granted regulatory approval for marketing and sale in Australia. Acetadote, an injectable drug used to treat acetaminophen (paracetamol) overdose, was approved by the Therapeutic Goods Administration (TGA), the government agency responsible for regulating drugs and medical devices in Australia.

12 May 2010

Survey reveals Gamunex as preferred IGIV therapy among neurologists

Talecris Biotherapeutics, Inc., today announced results of a new survey showing that Gamunex® (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) is the preferred immune globulin intravenous (IGIV) among neurologists who indicated a brand preference. In the survey, conducted online by Harris Interactive® on behalf of Talecris, neurologists selected Gamunex over four times more often than all other available liquid IGIV therapies, with a statistically significant margin (p<0.05).

13 Apr 2010

Cumberland Pharmaceuticals submits Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose.

30 Mar 2010

Novartis' Tasigna capsules granted priority review by FDA for treatment of adult patients with Ph+ CML

Novartis announced today that Tasigna® (nilotinib) 200 mg capsules has been granted priority review by the US Food and Drug Administration for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

19 Feb 2010

FDA approves Labopharm's OLEPTRO antidepressant for MDD

Labopharm Inc. today announced the U.S. Food and Drug Administration (FDA) has approved OLEPTRO(TM) (trazodone hydrochloride) Extended Release Tablets, a novel once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD) in adults. OLEPTRO(TM) utilizes CONTRAMID(R), Labopharm's clinically validated technology that controls the release of active substances within oral medications.

3 Feb 2010