Histamine News and Research

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Histamine is a biogenic amine chemical involved in local immune responses as well as regulating physiological function in the gut and acting as a neurotransmitter.

Elorac acquires world-wide rights to Cidoxepin

Elorac, Inc., a rapidly growing specialty pharmaceutical company focused on the treatment of dermatological disorders, is pleased to announce that it has acquired world-wide rights to the active agent Cidoxepin from Gideon Pharmaceuticals. Cidoxepin is the cis-isomer of the widely prescribed tricyclic compound doxepin.

19 Oct 2010

ISTA Pharmaceuticals announces Phase 1/2 clinical study results of bepotastine besilate nasal spray

ISTA Pharmaceuticals, Inc., today announced positive preliminary results from a Phase 1/2 clinical study of bepotastine besilate nasal spray conducted in Canada for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies.

6 Oct 2010

Forest Laboratories reveals top-line results from cariprazine Phase II clinical trial for bipolar depression

Forest Laboratories, Inc. and Gedeon Richter Plc. today announced preliminary top-line results from an 8-week Phase II clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of bipolar depression. Cariprazine is currently undergoing Phase III trials for separate indications of schizophrenia and bipolar mania.

30 Aug 2010

Epicept receives refusal to file letter on new drug application

EpiCept Corporation today announced that it received a refusal to file letter from the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Ceplene(histamine dihydrochloride).

23 Aug 2010

Research on gut mucosa enables effective drug treatment for irritable bowel syndrome

Irritable bowel syndrome makes life miserable for those affected an estimated ten percent or more of the population. And what irritates many of them even more is that they often are labeled as hypochondriacs, since physical causes for irritable bowel syndrome have never been identified. Now, biologists at the Technische Universitaet Muenchen (TUM) have shed new light on the matter: They have discovered mini-inflammations in the mucosa of the gut, which upset the sensitive balance of the bowel and are accompanied by sensitization of the enteric nervous system.

20 Aug 2010

Cobalis, BESPHarma partner to launch national distribution program for PreHistin Allergy Defense Formula

Cobalis Corp. announced today that it has entered into a 5-year distribution partnership agreement with Florida-based BESPHarma, LLC to launch a national distribution program wherein physicians and healthcare providers can offer their patients PreHistin Allergy Defense Formula directly in their offices.

6 Aug 2010

Phase 1/2 clinical study of bepotastine besilate nasal spray initiated for seasonal allergic rhinitis

ISTA Pharmaceuticals, Inc., today announced it has initiated a Phase 1/2 clinical study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. The randomized, placebo-controlled, parallel-group study will evaluate the safety and efficacy of three concentrations of bepotastine besilate, dosed twice daily, in an Environmental Exposure Chamber model of allergic rhinitis caused by natural exposure to seasonal allergens.

14 Jul 2010

EpiCept requests FDA priority review of Ceplene NDA for AML

EpiCept Corporation announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Ceplene® (histamine dihydrochloride). EpiCept is seeking approval for Ceplene, administered concomitantly with low-dose interleukin-2 (IL-2), for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML) in first complete remission.

29 Jun 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

Merck's DULERA Inhalation Aerosol for asthma receives FDA approval

Merck today announced that the U.S. Food and Drug Administration (FDA) has approved DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate).

24 Jun 2010

Extract of French maritime pine tree bark reduces hay fever symptoms

An estimated 60 million people in the U.S. are affected by allergic rhinitis, commonly known as hay fever, according to the American Academy of Allergy Asthma and Immunology. Hay fever is an allergic inflammation of the nasal airways that causes itching, swelling, mucus production, hives and rashes. A study published in the June 14, 2010 issue of Phytotherapy Research demonstrates Pycnogenol- (pic-noj-en-all), an antioxidant plant extract derived from the bark of the French maritime pine tree, substantially improves the symptoms of hay fever.

24 Jun 2010

Positive results from VIVUS' Phase 3 study of avanafil for ED in men with diabetes

VIVUS, Inc. today announced positive results from the phase 3 REVIVE-Diabetes (TA-302) study, evaluating the safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED) in men with type 1 and type 2 diabetes. The REVIVE-Diabetes study met all three primary endpoints across the two doses studied by demonstrating statistically significant improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score.

7 Jun 2010

Phase 3 pivotal REVIVE study data of VIVUS' avanafil for ED presented at 2010 AUA

VIVUS, Inc. today announced that data from the previously reported phase 3 pivotal REVIVE (TA-301) study, evaluating the safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED), were presented at the American Urological Association (AUA) 2010 Annual Meeting.

2 Jun 2010

EpiCept provides update on post-approval commitments requested by EMA for Ceplene

EpiCept Corporation today provided an update on the post-approval commitments requested by the European Medicines Agency as part of its marketing authorization for Ceplene (histamine dihydrochloride). Ceplene is approved in the EU for remission maintenance and prevention of relapse in adults with Acute Myeloid Leukemia in first complete remission.

1 Jun 2010

Cobalis submits Form of Order with US Bankruptcy Court

Cobalis Corp announced today that the Company's attorneys have submitted a Form of Order consistent with the United States Bankruptcy Court's ruling of April 7, 2010 confirming the debtor's plan of reorganization.

26 May 2010

EpiCept launches Ceplene in Germany

EpiCept Corporation today announced the commercial launch of Ceplene (R) (histamine dihydrochloride) in Germany. The launch is being conducted by Meda AB, as part of an exclusive commercialization agreement for Ceplene signed by the two companies in January 2010.

21 May 2010

Arena Pharmaceuticals reports lower net loss of $31.3 million in first-quarter 2010

Arena Pharmaceuticals, Inc. today reported financial results for the first quarter ended March 31, 2010.

7 May 2010

Researchers to identify rare genetic mutation to produce histamine against TS

A single, very unusual family with Tourette syndrome has led Yale School of Medicine researchers to identify a rare mutation in a gene that is required to produce histamine. The finding provides a new framework to understand many years of data on the role of histamine function in the brain and points to a potentially novel approach to treatment of tics and Tourette.

6 May 2010

Meda AB's net sales for first-quarter 2010 decrease 14% to SEK 2,943M

After a strong Q4 in 2009, net sales decreased 14% in Q1 to SEK 2,943 million (3,437). Mainly currency effects but also increased competition for Astelin and Optivar reduced sales by more than SEK 400 million, compared with the same period last year.

5 May 2010

Ocera Therapeutics presents Phase 2 proof-of-concept study results of AST-120 in non-constipating IBS

Ocera Therapeutics, Inc. presented results yesterday from a Phase 2 proof-of-concept study of AST-120 (spherical carbon adsorbent) in the treatment of patients with non-constipating Irritable Bowel Syndrome (IBS) at DDW, the annual meeting of the American Gastroenterological Association. Data showed that subjects treated with AST-120 responded in a consistent manner with reduction in pain better than placebo at week four and at week eight, the primary time point for analysis. The company plans to initiate a Phase 2b study evaluating AST-120 in non-constipating IBS.

4 May 2010