HomeNon classéUPRIMA ® apomorphine, co-marquetting avec Ixense ®

UPRIMA ® apomorphine, co-marquetting avec Ixense ®

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Voir ===> : Infor­ma­tion com­plète en fran­çais (Juin 2001)

TAP Hol­dings, a joint ven­ture bet­ween Take­da Che­mi­cal Indus­tries (Japan) and Abbott Labo­ra­to­ries (U.S.), will apply for FDA appro­val of Upri­ma (apo­mor­phine) in mid-1999.

Upri­ma works in a dif­ferent man­ner than Pfi­zer’s Via­gra and will become the second class of oral medi­ca­tions avai­lable to impo­tent men. In the future, Via­gra and Upri­ma may be used toge­ther to improve efficacy.

Three phase III stu­dies were recent­ly pre­sen­ted at the Ame­ri­can Uro­lo­gi­cal Asso­cia­tion mee­ting in Dal­las, Texas on May 4, 1999. It is anti­ci­pa­ted that TAP will uti­lize these three stu­dies in sup­port of their New Drug Appli­ca­tion in mid-1999.

How It Works

Upri­ma is a dopa­mine recep­tor ago­nist that acts on the cen­tral ner­vous sys­tem. Once absor­bed and trans­por­ted into the brain, Upri­ma ini­tiates a chain of reac­tions that result in increa­sed blood flow to the male geni­tal organs and an erection.

Cli­ni­cal Stu­dy Results

In mul­ti­cen­ter, double-blind stu­dies, patients were ran­do­mi­zed to one of four treat­ment arms of Upri­ma (2 mg, 4 mg, 5 mg, 6 mg) ver­sus pla­ce­bo. The main out­come mea­sure was the num­ber of attempts resul­ting in an erec­tion firm enough for intercourse.

The first stu­dy enrol­led 520 male erec­tile dys­func­tion patients. Results indi­ca­ted that patients who were ran­do­mi­zed to Upri­ma demons­tra­ted a signi­fi­cant­ly higher per­cen­tage of attempts resul­ting in an erec­tion firm enough for inter­course ver­sus placebo.

Two stu­dies inclu­ded hyper­ten­sive patients and sho­wed simi­lar results among this sub­po­pu­la­tion. This is impor­tant because erec­tile dys­func­tion is often asso­cia­ted with hyper­ten­sion. Among the 977 patients eva­lua­ted in the stu­dies, of which 236 had high blood pres­sure, it was found that those using Upri­ma demons­tra­ted a signi­fi­cant­ly higher per­cen­tage of attempts resul­ting in an erec­tion firm enough for inter­course ver­sus placebo.

In all stu­dies, the patients who recei­ved the highest dose of Upri­ma (6 mg) had an approxi­mate 60% effect com­pa­red to the 30% effect for those who recei­ved placebo.

What The Patient Should Know
Repor­ted side effects of Upri­ma include nau­sea that is pri­ma­ri­ly mild-to-moderate.

Refe­rences
1.Abbott Labo­ra­to­ries. Press Release, Abbott Labo­ra­to­ries 1999 May 4.
2.Meinhardt W, Krop­man RF, Ver­meij P. Com­pa­ra­tive tole­ra­bi­li­ty and effi­ca­cy of treat­ments for impo­tence. Drug Saf. 1999 Feb;20(2):133–46.

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