Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vardenafil ODT · 2 trials · 1 indication
The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: \<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \>25 'no ED'.)
SEP (Sexual Encounter Profile) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.
SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.
| Arm | Type | Description |
|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | EXPERIMENTAL | Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. |
| Arm1 | EXPERIMENTAL | - |
| Arm2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | DRUG | Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT) |
| Placebo | DRUG | Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet |
| Vardenafil ODT, (Staxyn, BAY38-9456) | DRUG | Single dose of 10 mg of vardenafil ODT, taken without water |
Inclusion Criteria: * Males 18 years-of-age or older. * Stable, heterosexual relationship for at least 6 months. * A history of erectile dysfunction (ED) for at least 6 months Exclusion Criteria: * Any underlying cardiovascular condition, including unstable angina pectoris * History of myocardial...
Vardenafil ODT is used to treat erectile dysfunction in adult men. It is an orally disintegrating tablet formulation that dissolves without water. The clinical development program for this formulation includes a Phase 3 trial in males with erectile dysfunction, half of whom were 65 years or older.
Vardenafil ODT works as an inhibitor of PDE5A, the phosphodiesterase type 5 enzyme. By inhibiting PDE5A, the drug supports the signaling pathway that promotes blood flow needed for erection. This mechanism is the same class of action used across PDE5 inhibitor therapies for erectile dysfunction.
Vardenafil ODT is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical trials evaluating this orally disintegrating tablet formulation of vardenafil.
Vardenafil ODT has reached Phase 3 development for erectile dysfunction. The Phase 3 trial in the program is completed, and the overall program includes two completed trials with a combined enrollment of 381 participants. The studies were randomized, double-blind, and placebo-controlled.
Vardenafil ODT has been studied in two completed trials. NCT00655629 was a Phase 3 trial comparing the orodispersible tablet to placebo in males with erectile dysfunction, enrolling 339 participants across the United States, Australia, Canada, and Mexico. NCT01348880 was a Phase 1 nifedipine interaction study enrolling 42 participants in the United States.
Yes, Vardenafil ODT is also known as Staxyn and by the development code BAY38-9456. Staxyn refers to the orally disintegrating tablet form of vardenafil, which is distinct from the standard vardenafil tablet formulation.