Buspirone chemical structure
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Buspar

Buspirone (brand-names Ansial®, Ansiced®, Anxiron®, Axoren®, Bespar®, Buspar®, Buspimen®, Buspinol®, Buspisal®, Narol®) is an anxiolytic drug. more...

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It shows no potential for addiction compared to other drugs commonly prescribed for anxiety, especially benzodiazepine medications. The development of tolerance has not been noticed. Cross-tolerance to benzodiazepines, barbiturates and alcohol does not exist. Furthermore, it is non-sedating. It is thought to act by interfering with the function of the neurotransmitter serotonin in the brain, particularly by serving as a 5-HT1A receptor partial agonist. Additionally, it acts as a mixed agonist/antagonist on postsynaptic Dopamine receptors. GABA-mediated effects are lacking. Buspirone may also have indirect effects on other neurotransmitters in the brain. The action of a single dose is much longer than the short halflife of 2-3 hours indicates.

The bioavailability of Buspirone is very low and variable due to extensive first pass metabolism. The drug is quickly resorbed. Taking the drug together with food may increase the bioavailabilty. The drug is highly (95%) plasma-bound. The active metabolite 1-PP is also a 5-HT1A partial agonist with anxiolytic properties, but weaker so than the mother-drug.

Bristol-Myers Squibb gained FDA approval for Buspirone in 1986. The drug went generic in 2001.

It is also useful as an augmenting agent, for the treatment of depression, when added to SSRIs (selective serotonin reuptake inhibitors).

The main disadvantage is that 1 to 3 weeks elapse before the anxiolytic activity becomes evident. Often patients have to be initially cotreated with a benzodiazepine for immediate anxiolysis. Generally, Buspirone works less well than benzodiazepines. It is particular difficult to treat patients pretreated with benzodiazepines knowing the immediate effects of these tranqulizers.

Indications

  • Generalized anxiety disorder of mild to moderate intensity

N.B. Busprirone is definitively not effective against other types of panic disorders with or without agoraphobia and social phobia.

  • Augmention of SSRI-Treatment against Depression

Contraindications

  • Myasthenia gravis
  • Acute closed angle glaucoma
  • Severly compromised liver- and renal-function
  • Concomittant treatment with a MAO-Inhibitor (severe hypertensive crises have been seen)
  • Caution : Preexisting heart conditions (e.g. myocardial infarction)

Side-effects

Rarely, side-effects have a dangerous nature or intensity. Some tend to disappear with continued therapy, or are less frequent if the initial dose is low and increased gradually (vertigo, agitation, insomnia).

  • Most frequent: vertigo, headaches, nervousness, agitation, light-headedness, nausea;
  • Often (>1%) : drowsiness, insomnia, concentration disorders, confusion, depression, agitation, intestinal disorders, paresthesia, coordination disorders, tremors, disturbed visus, tinnitus, fatigue, weakness, Angina pectoris, sore throat, tachycardias, palpitations, dry mouth, pain in muscles and joints;
  • Seldomly: allergic reactions, subdermal bleeding, extrapyramidal symptoms, hallucinations, psychosis, ataxia, epileptic seizures, syncope, tunnel vision, urine retention, alopecia, pruritus.

The dyscognitive side-effects of benzodiazepines are lacking completely.

Read more at Wikipedia.org


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Generic BuSpar clears last hurdle; BMS patent claims found 'baseless.' - Pharmacy News Briefs - Bristol-Myers Squibb - Brief Article
From Drug Store News, 3/4/02 by James Frederick

PITTSBURGH -- The end of the long legal tangle between Bristol-Myers Squibb and would-be generic makers of the anti-anxiety drug BuSpar (buspirone) came into sight after a U.S. District Court judge ruled in favor of one generic company seeking to sell the drug.

U.S. District Court Judge John Koeltl granted generic drug maker Mylan a summary judgement that essentially says its sale of buspirone does not infringe on BMS' BuSpar patent or any other lingering claims on the drug. In his Feb. 19 decision, the judge called BMS' claims and the subsequent patent infringement suit "objectively baseless."

Among BMS' contentions was a claim that BMS owned the right to a metabolite produced in the bodies of BuSpar users.

"We are pleased with this court decision, which we think should be viewed as a significant victory for the entire generic industry and for all consumers who rely on more affordable prescription drugs," Mylan chairman and chief executive officer Milan Puskar said. The court also denied Bristol-Myers Squibb's motion to dismiss Mylan's anti-trust counterclaims. Litigation of those claims, Mylan said, will proceed.

Even with uncertain availability of the generic version, BMS said BuSpar sales dipped 52 percent to $338 million in the fourth quarter. Mylan was the first generic drug approved to market 30 mg tablets of buspirone, in June 2001, but BMS court challenges prevented its consistent availability and distribution.

COPYRIGHT 2002 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2002 Gale Group

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