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Chemical PE for all

Chemical PE for all…article/1298053


Vitaros contains alprostadil, identical to naturally occurring prostaglandin E1, which causes vasodilatation of blood vessels in the corpora cavernosa and an increase in cavernosal artery blood flow, resulting in penile rigidity.1

The efficacy of alprostadil in the treatment of ED is well established when administered by intracavernosal injection or via a transurethral stick.2

Vitaros contains 300 microgram alprostadil in a cream formulation for topical application to the meatus of the penis. The cream incorporates a skin-permeation enhancer that aids absorption of alprostadil through the glans. After application, the onset of action is within five to 30 minutes and the effect lasts for 1-2 hours after dosing.1

Vitaros was assessed for efficacy and safety in two pivotal phase III, double-blind, parallel-group studies in 1732 men aged 21 years and older with a history of ED for at least three months. Among the participants, 22% had diabetes, 29% had cardiac disorders, 13% had undergone prostatectomy and 19% had failed to respond to sildenafil.3

Following initial assessment and a four-week run-in period, patients were randomised to receive topical alprostadil cream (100, 200, or 300 microgram per unit dose) or placebo for use at home as required over 12 weeks. They completed a sexual encounter profile (SEP) diary to record attempts at intercourse.3
Efficacy outcomes

The primary efficacy measures were change from baseline to final visit score in the erectile function domain of the International Index of Erectile Function (IIEF) and final visit responses for SEP questions 2 and 3 (relating to successful vaginal penetration and ejaculation, respectively). Patient satisfaction was also assessed using the Global Assessment Questionnaire, where the patient was asked “When using the study medication, did you feel your erections improved?”.3

In an integrated analysis of the combined intention-to-treat population from the two trials, all three doses of alprostadil produced statistically significant improvements in IIEF erectile function scores (ranging from +1.7 to +2.5), compared with placebo (–0.7; p≤0.001 for all comparisons). Similar significant improvementsin SEP successful vaginal penetration and ejaculation scores were observed for all doses (p≤0.001 for all).3

Patient satisfaction showed a significant dose-dependent improvement over placebo for all alprostadil doses at 12 weeks: 40% of the 100-microgram group, 47% of the 200-microgram group and 52% of the 300-microgram group reported improved erections, compared with 20% of the placebo group (p<0.001 for all).3
Localised adverse events

Localised penile irritation, including burning, pain and erythema, was the most commonly observed adverse reaction, but was generally transient and mild to moderate in severity. Adverse reactions (eg, vaginal burning) may also occur in partners of patients using topical alprostadil, so use of latex condoms is advised and must be ensured for sexual intercourse with women who are of childbearing potential, pregnant or lactating.1,3

From what I understand alprostadil is what caverject is made of. This topical version seems to be a bit less efficient, but I guess depending on the dosage things could be different.

Via transutheral stick should be MUSE? It has been a failure as far as I know.

No it is not the same, it was approved for use last month. You only pour a drop of the product in/on the meatus (no intra urethral stick).

Follows a 1-2 hour erection . From what I have seen results have been positive, not as effective as injections, so depending on the reason for ED it could be useless.

The main advantage is it’s not systemic (at least much less than injections).

FDA rejects Apricus Bio’s ED cream Vitaros

Feb. 16, 2018 7:09 AM ET|about: Apricus Biosciences, Inc (APRI)|By: Douglas W. House, SA News Editor
Apricus Biosciences (NASDAQ:APRI) is set for an ugly day after receiving a Complete Response Letter (CRL) from the FDA regarding its marketing application for topical erectile dysfunction (ED) cream Vitaros (alprostadil, DDAIP.HCl).

The CRL cited deficiencies in Chemistry, Manufacturing and Control and safety concerns specific to the 2.5% concentration of DDAIP. HCl in the current formulation.

CEO Richard Pascoe says, “We are disappointed with the outcome of the review given the substantial amount of CMC, clinical and non-clinical data and analysis provided to the FDA in the Vitaros resubmission. We are assessing the content of the complete response letter with our regulatory experts, including the information that may be needed to resolve the deficiencies and the time it would take to obtain such information with the goal of providing the market an update on our assessment in early March of this year.”…d-cream-vitaros

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“The CRL cited deficiencies in Chemistry, Manufacturing and Control and safety concerns specific to the 2.5% concentration of DDAIP.HCl in the current formulation.”

That sounds like a well thought-out quality product.

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