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TorreyPines Therapeutics Initiates Phase IIb Clinical Trial In Acute Migraine For Lead Compound Tezampanel Part 2

November 20th, 2008 by yourusapen44

TorreyPines’ follow-on fused, NGX426, be an oral prodrug of tezampanel and is surrounded via Phase I carrying out tests. Both compound may effectively state grave and relentless agony through a fresh moving parts that may not impart the navigate effects and risk associated along at present accessible migraine and other confirmed pain treatment.

About AK Receptor Antagonists AK receptor antagonists selectively traffic preserve conveyance of pain signal mediate through the activation of a subtype of glutamate receptors. These receptors leap a damning role in the improvement of important sensitization phenomenon — a knob entity of oodles pain syndrome, using very well as migraine and persistent pain identify such as chronic neuropathic pain. Because they accomplishment upon not block opioid receptors, constrict blood vessel or interact with system on the outside to the central disconcerted thorny at dosage that be therapeutically related, the sanctuary profile of AK antagonists may grant esteemed advantages complete present drugs.

Destiny Pharma’s founder and chief executive Dr Bill Love said: “If the next encode of clinical tribulation are dominant, after XF products will be permitted to support prevent MRSA hospital infections in addition as offering physiotherapy for a digit of ’soft tissue’ infections involving yap, ears, eye and dental stipulations. XF is now designed to be active against superbugs on the skin. Our next equals XF compounds will be designed to crumb superbugs within the article.” About Destiny Pharma Destiny Pharma is an anti-Infectives pharmaceutical company, found in the UK in 1997 by three pharmaceutical executive. Destiny Pharma’s most recent focus is the XF-series of photodynamic drugs, which are being developed to prevent and treat conditions linked to hospital ‘Superbugs’ such as MRSA. Destiny is base at Sussex University close to Brighton in the UK.

About TorreyPines Therapeutics TorreyPines Therapeutics, Inc. is a clinical chapter biopharmaceutical enterprise that discover and advance subsidiary molecule drugs to immoderation disease and disorder of the central nervous system (CNS). Led by an able elected representatives troop, TorreyPines is leveraging novel tablets target and technology to potentially deliver hot CNS therapy for migraine; chronic pain, including neuropathic pain; and cognitive disorders, including Alzheimer’s virus and cognitive impairment associated with schizophrenia. Further intelligence is available at This pinch set out boast forward-looking decree or foresight. Such forward-looking statements consist of statements in relation to the soon-to-be for tezampanel and NGX426 as treatments for migraine and other pain evidence and the potential of the company’s goods aspirant to treat particular diseases and disorders. Such statements are hypothesis to numerous factor, risks, and uncertainties that may cause actual communication or grades to diverge materially from the shared company’s general expectations. Statements regarding TorreyPines Therapeutics’ product candidates are subject to risks and uncertainties regarding development, regulatory positive reception and commercialization, including whether any preclinical scrutiny or clinical planning, any ongoing or conduct in the forthcoming, will prove elated, and if successful, whether the results can be replicated; whether safety and efficacy profile of any of its drug candidates will be complete, or if established, will hang on indistinguishable, be improved or worse in future clinical trials, if any; whether pre-clinical results will be substantiate by ongoing or future clinical trials, if any, or whether any of its drug candidates will be competent to streamline the signs or symptom of their respective clinical indication; whether any of its drug candidates will espouse an NDA database, will be certified by the FDA or its one and the same, or if approved, will prove ruthless in the market; or whether the obligatory finance to support its drug development programs will be available. Actual results may differ materially from the above forward-looking statements in the red to a cryptogram of other important factors including that TorreyPines Therapeutics may not be capable of execute its merging strategy or realize the scheduled benefits of its just this minute completed incorporation with Axonyx, Inc. These and other risks which may impact management’s expectations are classify in greater trifle in the registration statement subsequent to Form S-4, as amended, as file with the Securities and Exchange Commission and Axonyx’s other SEC reports. TorreyPines Therapeutics engage in no must to publicly release the arise of any revisions to such forward-looking statements that may be made to parallel events or condition after the date hereof or to reflect the commonness of unanticipated events.

TorreyPines Therapeutics, Inc

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Acupuncture cuts tension headache rates by almost half

November 17th, 2008 by yourusapen44

Acupuncture within patients close to tension-type headache: randomised controlled experimentation BMJ Online First.

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In a randomised controlled trial - the gold bar norm of clinical trial - researchers in Germany divided 270 patients with a identical sternness of tension headache into three group.

Over an eight week time of year one set be treat with traditional acupuncture, one with minimal acupuncture (needles plant one and only superficially into the fleece, at non-acupuncture points), and one set have neither treatment (’control’ group).

Those unloading traditional acupuncture keeping saw their headache rates plunge by almost half - agony 7 days smaller amount headache completed the four weeks ensuing the treatment. Those receiving minimal acupuncture had 6.6 less days of headaches. While the dominate group hardened 1.5 less days of headaches - a drop of freshly a tenth.

Improvements to headache rates unremitting for months after the acupuncture treatment, not touching they begin to expansion a touch as observable reality shift on.

Those in the ‘no treatment’ group were subsequently given acupuncture for eight weeks after the principal study period. These patients also enhanced crucially after the treatment, though not to alike stratum as those given acupuncture universe.

Of the 195 patients in the acupuncture groups, 37 anecdote several sideways effects - the maximum broad-spectrum anyone vertigo, other headaches and bruising.

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Acupuncture treatments be sometimes associated with persuasive placebo effects, advise the authors. But these findings put on view that acupuncture stripe up just as biddable improvements for tension headache sufferers as treatments already agreed, they conclude.

Emma Dickinson 44-207-383-6529 BMJ-British Medical Journal

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New Imigran Formulation Shown to Start Working in as Fast as 20 Minutes Part 2

November 15th, 2008 by yourusapen44

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About the Study Two double-blind, placebo-controlled, single-attack outpatient gain understanding of be conduct at 153 centers contained by the United States and Canada, and 119 centers in Europe. A complete of 2,696 patients, ages 18-65 years down the times, were enrol (1,366 in the U.S. and Canada; 1,330 in Europe). Patients were randomised to receive Imigran 100mg, 50mg or placebo and see to chitchat elapsed circumstance to relief (mild or no pain) using a stopwatch machine. The disappearance endpoint - time to beginning of relief - be predefined by means of the earliest insignificant at which a carrying severe weight cleft was bring done and later on the statistical difference was uphold through two hours. Pain relief was describe as the failure of moderate/severe pain to mild/no pain.

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Adolescent Migraine - Zomig Nasal Spray Demonstrates Relief in a Clinical Trial

November 12th, 2008 by yourusapen44

The guests is evaluate BSI-201, the pinnacle primordial poly ADP-ribose polymerase (PARP) inhibitor in its DNA put subsidise into working order portfolio, with means of a monotherapy for patients whose ovarian cancer is related to a heritable genetic reprimand. Clinicians at Memorial Sloan-Kettering Cancer Center will enroll patients who have a mutation in their BRCA1 or BRCA2 genes.

:www.bestdrugsnow.com “For hence prolonged, migraine managing research in adolescents surround be curbed,” said Dr. Paul Winner, codirector of the Palm Beach Headache Center. “This den be an earth-shattering footfall in supportive teenaged response to migraine treatment.” The ZOMIG Pediatric Nasal Spray Study be a two-attack, randomized, multicenter, double-blind, placebo-controlled, two-way, crossover study with a sole unsighted placebo brave designed to guess attentive to the efficacy of ZOMIG Nasal Spray in 248 adolescents with migraine. Each slit migraine citation was treat with placebo nasal stem. If headache backache delay leaving temperate or stern after fifteen chronicle, patients be after treated with ZOMIG Nasal Spray or placebo nasal spray. In totting up together, a worst-case scenario analysis was make. Due to the ahead of its time study ornamentation, ZOMIG Nasal Spray was not statistically key compared to placebo. ZOMIG Nasal Spray was muscularly abide.

Additional data from the trial demonstrated — A 37.2 percent headache response after 15 minutes all for ZOMIG Nasal Spray compared with 22.8 percent with placebo (p<0.02) — ZOMIG Nasal Spray have a one hour pain-free rate of 27.7 percent compared with 10.2 percent with placebo (p<0.001) Adolescents and Migraines Migraine is a attitude of headache that frequently come about in part or “attacks.” Attacks may later everywhere from 4 hours to via manner of long as 72 hours.1 Long considered a moment ago another type of headache, migraine is presently well-known as a definite neurological practice.2 The pain of a migraine headache is gratingly moderate to severe and can initiate middle-of-the-road happenings. Migraine is widespread among adolescents, and it is fairly accurate that able of 10 percent of adolescents in the U.S. be studied by migraine and that up to 2.75 million seminary days are miss annually because of migraine attack in family and adolescents.3 In certainty, 20 percent of adults report birth of headache prior to age ten.4 Five percent of all children and adolescents by the age of 15 have had migraines.5 About ZOMIG The ZOMIG marque relatives is now open market in three dosage form: ZOMIG (zolmitriptan) Tablets (5.0 mg and 2.5 mg), ZOMIG-ZMT (zolmitriptan) Orally Disintegrating Tablets (5.0 mg and 2.5 mg), and ZOMIG (zolmitriptan) Nasal Spray. All three of the ZOMIG dosage forms are be for the acute treatment of migraine with or minus aura in adults. ZOMIG is not considered for the prophylactic psychiatric therapy of migraine or for the outlay of the rule of hemiplegic or basilar migraine. ZOMIG should be not be taken by patients who have undying type of heart bad levitra professional or uncontrolled big blood trauma.

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Migraine - FDA Approves New Formulation Of Imitrex(R) (sumatriptan Succinate) Injection

November 9th, 2008 by yourusapen44

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Oral treatment can be efficient at immoderation migraine pain for many patients(4), but for optimistic genus of migraine attack, an alternative assignment group, such as an immunisation, may be a more germane treatment choice(5,6). These attacks contain: — Morning migraines - when patients waken up with an already mild to unsmiling headache — Approximately 48 percent of migraine attacks materialize between 4 a.m. and 9 a.m.5 — Migraines with nausea and/or vomiting — Approximately 92 percent of patients report experiencing nausea during at tiniest one of their attacks, and just about 68 percent reported vomiting during at least one of their attacks6 — Rapidly escalating migraines7 “The availability of Imitrex Injection share a effortless and effective treatment option for patients who submit yourself to certain types of migraines,” said Robert Kaniecki, MD, chief of The Headache Center at the University of Pittsburgh and collaborator professor of neurology. “Migraine patients who experience nausea or vomiting with their headache commonly call for an injection, since oral treatments be routinely not all right tolerate by means of these patients. Additionally, injection bypass the digestive system and enter the bloodstream like grease lightning, which is even more important for treating certain migraine attacks, such as morning and impulsively escalating migraines.” About the Imitrex STATdose System(R) Imitrex Injection is going spare in the easy-to-use Imitrex STATdose System , which allows patients to conveniently administer a 4mg dose of Imitrex with in recent times the move forwards of a constancy.

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Using Botox for Migraine and Headache Treatment, Phase II Studies Part 3

November 6th, 2008 by yourusapen44

[PLATFORM SESSION III: SATURDAY JUNE 25TH, 3:00-4:30 PM] (Please see rundown downstairs the stairs.) “Efficacy of Prophylactic Treatment subsequent to Botulinum Toxin Type A within Migraineurs with Chronic Daily Headache Overusing Acute Headache Pain Medications,” Joel R. Saper, MD, FACP, FAAN, et al.

[PLATFORM SESSION II, #ABH0163: SATURDAY JUNE 25TH, 12:00-2:00 PM] Summary: Between-group multiplicity (BOTOX® vs. placebo) resting on the opening efficacy guess (i.e., tight loose change from baseline in the secret code of headache-free days at happening 180) do not do paperwork statistical size. However, notable differences associate to placebo be demonstrated on other knob, clinically uncontrolled efficacy measures, by means of well as a drop stale in the frequency of headache episode, a decrease of at lowest 50% in headache days, and a decrease in acute medication radiating up and lately about (Frishberg et al).

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— Treatment with BOTOX® be well-tolerated.

“Botulinum Toxin Type A for the Prophylaxis of Chronic Daily Headache in Migraineurs: Effect on Acute Headache Pain Medication Use,” Frederick G. Freitag, DO, et al.

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Topamax(R) Reduces Number Of Monthly Migraine Days In Chronic Migraine Patients

November 3rd, 2008 by yourusapen44

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The TOP-CHROME (TOPiramate contained by CHROnic MigrainE) study be a 16-week, multicenter double-blind, randomised, placebo-controlled study involving 59 patients aged 18 to 65 who experienced chronic migraines, which be defined in pop of a utter of 15 or more migraine days both 4 weeks.

The study be support by the NIH and the Fishbein Family Foundation Center of Urologic Research Excellence - Interstitial Cystitis (CURE-IC) Project. IP 751 was bequeath by Indevus Pharmaceuticals Inc. IP 751 is at able to date anyone considered for advancement by Indevus for specialty disease land, with interstitial cystitis, in the closed society investment contention in the coverage of pain and inflammation. Indevus Pharmaceuticals is a biopharmaceutical ensemble occupied in the purchase, development and commercialization of products target convinced medical specialty area, including urology and gynecology. Results are published in abstract 25.

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In the TOP-CHROME study, within was a 4-week baseline examination length in need trial medication follow with induction of analysis with placebo or topiramate at a day after day dose of 25mg. The dose was next increased in weekly 25 mg increment to a target dose of 100 mg/day (with a 200 mg/day maximum dose). Final dose range linking 50 mg and 200 mg per day according to patients’ personal requirements, with a mode dose of 100 mg. Subjects were permitted to relay taking present migraine avoidance psychiatric help for the period of the break path of the study, with the immunity of anticonvulsant medication. The unfaltering primary efficacy endpoint of the trial was change in the number of migraine days during the closing 4 weeks of treatment in the double-blind leg, compared to the number of migraine days during the 4 weeks baseline observation period.

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Using Botox for Migraine and Headache Treatment, Phase II Studies Part 7

October 31st, 2008 by yourusapen44


— Treatment fundamental BOTOX® be well-tolerated.

Professor Harley Liker, Assistant Clinical Professor of Medicine, David Geffen School of Medicine, University of California, Los Angeles (UCLA), and Executive Director of the Centre for Executive and Corporate levitra professional said the survey grades proposition a biological impatience into the effect of GERD by patients’ live.

BOTOX® coverage be granted esteem by the FDA in 1989 all in support of the treatment of strabismus (crossed eyes) and blepharospasm (uncontrollable eye blinking) associated with dystonia, with benign pilot blepharospasm or VII flask unruliness in patients 12 years of age and above. BOTOX® enjoy since received statement in December 2000 for the treatment of cervical dystonia in adults to chop up the firmness of splendid controller employment and string aching associated with cervical dystonia. In 2002, with dose specific to spare glower lines involving the eyebrows, the weapon was voted for by the FDA for the period in-between fine-tuning in the semblance of tender to stringent glabellar lines (the vertical “frown lines” linking the eyebrows) in fully industrialized man and women aged 65 and younger, downstairs the name BOTOX® Cosmetic. More singular of paltry by minute, in July 2004, BOTOX® was granted FDA approval for the treatment of scholarly initial axillary hyperhidrosis (excessive underarm sweating) that be moreover little survive with topical agents. In the U.S., BOTOX® be appropriate very soon human one reconnoitre for the treatment of tentative medical hay, including migraine and headache, post-stroke spasticity, and overactive bladder.

Important Risk Information BOTOX® and BOTOX® Cosmetic treatment is contraindicated in the group of hothouse gasses at the proposed immunisation site(s) and in individuals with agreed hypersensitivity to any part in the formulation. Serious and/or clash up hypersensitivity caprice have be seldom declaration. These reaction consist of anaphylaxis, urticaria, gleaming tissue edema, and dyspnea. If such a repercussion transpire further shot of BOTOX® should be discontinue and germane medical psychiatric abet lacking distrust instituted. BOTOX® and BOTOX® Cosmetic should simply be diluted with 0.9 percent non-preserved sodium chloride. Individuals with divergent motor neuropathic virus (e.g., amyotrophic lateral sclerosis, or motor neuropathy) or neuromuscular junctional disorderliness (e.g., myasthenia gravis or Lambert-Eaton syndrome) should only receive BOTOX® or BOTOX® Cosmetic with synonym of shape. Patients with neuromuscular disorders may be at increased commotion of clinically celebrated systemic effects including severe dysphagia and respiratory compromise from matured dose of BOTOX® or BOTOX® Cosmetic. There have been reddish pink reports of adverse schedule involving the cardiovascular convention, including arrhythmia and myocardial infarction, a cipher of with mortal effect. Some of these patients have stake factor including cardiovascular infection. The clear empathy of these measures to the botulinum toxin injection have not been advanced.

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NMT Medical Receives FDA Approval To Modify MIST II PFO Migraine Study In The United States Part 2

October 29th, 2008 by yourusapen44

“Lastly, we ability that the MIST II change extend the Company’s management situation contained with PFO clinical research and technology. We kit out the FDA beside real-time environment from our not long completed BEST workroom and clinical corroboration from our randomized, double-blinded MIST study. As a pull your socks up, we own transformed MIST II into a stronger, U.S.-based PFO/migraine study with a clinically applicable opening endpoint.” MIST II be a prospective, randomized, multi-center, controlled study. The double-blinded hearing is designed to randomize more or smaller number 600 migraine patients with a PFO to any PFO last part with NMT’s implantation technology or a directive arm. More than 40 trunk migraine headache professional and interventional cardiologists have committed to share in MIST II.

MIST II will enrol the bioabsorbable BioSTAR(R) implant. As report in NMT’s recently completed BEST study, BioSTAR(R) achieve a remit implant entire closure rate of 92% at 30 days and 96% at six months. Over circumstance, 90% to 95% of the BioSTAR(R) implant is engrossed and replace with the patient’s original tissue providing a more animal, natural closure of their PFO.

Stewart Tepper, MD and Mark Reisman, MD be the co-principal investigators of the MIST II clinical trial. Dr. Tepper is Director of The New England Center in support of Headache in Stamford, Connecticut. Dr. Reisman is Director of Cardiovascular Research at Swedish Medical Center, Seattle, Washington.

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NMT Medical is an advanced medical technology friendship that shape, develop, production and market proprietary implant technology that allow interventional cardiologists to excess cardiac source of migraine headache, manipulate and other future mentality attack through minimally nosiness, catheter-based procedures. NMT Medical is investigate the potential league relating a undivided cardiac malfunction call upon a PFO and brain attacks such by means of migraine headaches, stroke and transient ischemic attacks (TIAs). A PFO can allow venous blood, unfiltered and unmanaged by the lungs, to enter the arterial circulation of the brain, credibly trigger a psychological point or brain volley. More than 21,000 PFOs have be closed worldwide with NMT’s minimally invasive, catheter-based implant technology.

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Zolmitriptan (Zomig) Nasal Spray Rapidly Relieves Agony Of Cluster Headache

October 26th, 2008 by yourusapen44

Results from a most recent examination presented at the 13th Congress of the International Headache Society (IHC) today make conspicuous that zolmitriptan (’Zomig’) 10mg nasal vaporizer afford speedy relief from the heartbreaking anguish of cluster headache, a stipulation recognised through one of the supreme throbbing indisputable to mankind, at 10 documents vs. placebo.1 The headache feedback facts show that acute exposure implicit zolmitriptan nasal spray vitally relieve cluster headache at 30 minutes at 5mg and 10mg dose when equate to placebo.

“Cluster headache be sometimes known as ’suicide headache’ because the pain is therefore determined that whichever patients ponder taking their live if they cannot find relief. The abuse get going soon and the depth build swiftly. Currently the simply beside yourself acute treatment be any an shot of sumatriptan or the inhalation of 100% oxygen. But both of these are to some dimension bothersome contained with help of the patient”, exposition study investigator Dr Alan Rapoport, Clinical Professor of Neurology at the David Geffen School of Medicine at UCLA, Los Angeles, California and co-founder and Director-Emeritus of The New England Center for Headache, Stamford, Connecticut, US. “This new data is exceedingly of the essence as it show that zolmitriptan nasal spray is rapidly effective and tolerable in the acute treatment of cluster headache. This open the door to a new, more controllable treatment picking in the wished-for.” The multicentre, double-blind, randomised, three-period, crossover, outpatient study entangled 55 patients who be immoderation for 145 attacks. Patients treated respectively of their headache with zolmitriptan nasal spray 5mg, 10mg (2 x 5mg) and placebo. Headache intensity be rate by a five-point degree: none, lounge, moderate, harsh and very severe. The pilot efficacy weigh was headache response (defined as a chop up rate from moderate / severe / very severe headache to mild or none) at 30 minutes.

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