STENDRA
Clinical Data

Learn about how STENDRA helps men, including those with diabetes, attain an erection and achieve successful intercourse.

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Time to onset of effect1

STENDRA worked in as little as ~15 minutes1

  • In a clinical trial, 25.9% (N=139) and 29.1% (N=139) of patients, taking 100 mg and 200 mg respectively, achieved an erection in as little as 15 minutes1
    • STENDRA 100 mg and 200 mg demonstrated statistically significant improvements relative to placebo1
    • Primary efficacy variable was the percentage of all attempts resulting in an erection sufficient for penetration at ~15 minutes after dosing followed by successful intercourse1
Percentage of Successful Intercourse (SEP3) Placebo (N=136) STENDRA 100 mg (N=139) STENDRA 200 mg (N=139)
Mean 14.9 25.9 29.1
Median 0.0 11.1 13.3
P value*   0.001 <0.001

*Change from baseline represents least-square estimate from ANCOVA model.

SEP3: "Did your erection last long enough to have successful intercourse?"

SEP=Sexual Encounter Profile.

STENDRA was evaluated in an 8-week, double-blind, placebo-controlled trial in which 440 men, including diabetics (16.4%) were randomized to receive STENDRA (100 mg, 200 mg) or placebo. Men were encouraged to attempt intercourse ~15 minutes after dosing and used a stopwatch for measurement of time to onset of effect, defined as the time to the first occurrence of an erection sufficient for sexual intercourse.1

Results from the REVIVE Study 1—General population

Nearly a 3-fold increase in erectile function with STENDRA 100 mg and 200 mg vs placebo1,2

Increase in erectile function with STENDRA 100 mg and 200 mg vs placebo in the general population Increase in erectile function with STENDRA 100 mg and 200 mg vs placebo in the general population

Change from baseline represents least-square estimate from ANCOVA model.

IIEF-EF=International Index of Erectile Function-Erectile Function.

The IIEF is a 4-week recall questionnaire that was administered at baseline and at 4-week intervals during treatment. The IIEF erectile function domain has a 30-point total score, where the higher scores reflect better erectile function.1

STENDRA was evaluated in a 12-week, double-blind, placebo-controlled, Phase 3 trial in which 646 men were randomized to receive STENDRA (50 mg, 100 mg, 200 mg) or placebo. Men were instructed to take study drug approximately 30 minutes prior to initiation of sexual activity. Food and alcohol intake were not restricted.1,2

The study assessed:

  • Erectile function
  • SEP2: "Were you able to insert your penis into your partner's vagina?"
  • SEP3: "Did your erection last long enough to have successful intercourse?"

SEP=Sexual Encounter Profile.

Results from the REVIVE Study 2—Men with diabetes

Greater than a 2-fold improvement in erectile function with STENDRA 100 mg and 200 mg vs placebo1,3

Improvement in erectile function with STENDRA 100 mg and 200 mg vs placebo in men with diabetes Improvement in erectile function with STENDRA 100 mg and 200 mg vs placebo in men with diabetes

Change from baseline represents least-square estimate from ANCOVA model.

IIEF-EF=International Index of Erectile Function-Erectile Function.

The IIEF is a 4-week recall questionnaire that was administered at baseline and at 4-week intervals during treatment. The IIEF erectile function domain has a 30-point total score, where the higher scores reflect better erectile function.1

STENDRA was evaluated in a 12-week, double-blind, placebo-controlled study that randomized 390 men with type 1 or type 2 diabetes and ED to receive STENDRA (100 mg, 200 mg) or placebo. Men were instructed to take study drug approximately 30 minutes prior to initiation of sexual activity.1,3

The study assessed:

  • Erectile function
  • SEP2: "Were you able to insert your penis into your partner's vagina?"
  • SEP3: "Did your erection last long enough to have successful intercourse?"

SEP=Sexual Encounter Profile.

*See savings card for terms and conditions.

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IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

Nitrates: Administration of STENDRA® (avanafil) with any form of organic nitrates, either regularly and/or intermittently, is contraindicated. STENDRA has been shown to potentiate the hypotensive effects of nitrates.

Concomitant Guanylate Cyclase (GC) Stimulators: Do not use STENDRA in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including STENDRA, may potentiate the hypotensive effects of GC stimulators.

Hypersensitivity Reactions: STENDRA is contraindicated in patients with a known hypersensitivity to any component of the tablet. Hypersensitivity reactions such as pruritus and eyelid swelling have been reported.

WARNINGS AND PRECAUTIONS

Cardiovascular Risks: Treatments for ED, including STENDRA, should not be used in men who have underlying cardiovascular conditions, or for whom sexual activity is inadvisable due to cardiovascular issues.

STENDRA is not recommended for the following:

  • Patients who have suffered a myocardial infarction, stroke, life-threatening arrhythmia, or coronary revascularization within the last 6 months
  • Patients with resting hypotension (blood pressure less than 90/50 mmHg) or hypertension (blood pressure greater than 170/100 mmHg)
  • Patients with unstable angina, angina with sexual intercourse, or New York Heart Association Class 2 or greater congestive heart failure

Concomitant Use of CYP3A4 Inhibitors: Inhibitors of CYP3A4 may reduce STENDRA clearance and increase plasma concentrations of avanafil. For patients taking concomitant strong CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, and telithromycin), do not use STENDRA. For patients taking concomitant moderate CYP3A4 inhibitors (including erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil), the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours.

Prolonged Erection: Prolonged erection longer than 4 hours and priapism (painful erections longer than 6 hours in duration) have been reported with other PDE5 inhibitors. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If not treated immediately, penile tissue damage and permanent loss of potency could result.

STENDRA should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).

Effects on the Eye: Physicians should advise patients to stop use of all PDE5 inhibitors, including STENDRA, and seek medical attention if a sudden loss of vision occurs in 1 or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Individuals with "crowded" optic disc are also considered at greater risk for NAION.

Sudden Hearing Loss: Use of PDE5 inhibitors has been associated with sudden decrease or loss of hearing, which may be accompanied by tinnitus or dizziness. Patients experiencing these symptoms should be advised to stop taking STENDRA and seek prompt medical attention.

Alpha-Blockers and Other Antihypertensives: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including STENDRA, and alpha-adrenergic blocking agents are both vasodilators with blood pressure-lowering effects. When used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these 2 drug classes can lower blood pressure significantly, leading to symptomatic hypotension (eg, dizziness, lightheadedness, fainting).

Alcohol: Patients should be made aware that both alcohol and PDE5 inhibitors, including STENDRA, act as vasodilators. When taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Physicians should inform patients that substantial consumption of alcohol (eg, greater than 3 units) in combination with STENDRA may increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.

Combination with Other PDE5 Inhibitors or ED Therapies: The safety and efficacy of combinations of STENDRA with other treatments for ED have not been studied. The use of such combinations is not recommended.

Effects on Bleeding: The safety of STENDRA is unknown in patients with bleeding disorders and patients with active peptic ulceration.

Counseling Patients About Sexually Transmitted Diseases: The use of STENDRA offers no protection against sexually transmitted diseases. Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including human immunodeficiency virus (HIV), should be considered.

ADVERSE REACTIONS

Adverse reactions ≥2% with STENDRA 50 mg, 100 mg, and 200 mg vs placebo, respectively: headache (5.1%, 6.9%, 10.5% vs 1.7%); flushing (3.2%, 4.3%, 4.0% vs 0.0%); nasal congestion (1.8%, 2.9%, 2.0% vs 1.1%); nasopharyngitis (0.9%, 2.6%, 3.4% vs 2.9%); and back pain (3.2%, 2.0%, 1.1% vs 1.1%).

INDICATION AND USAGE

STENDRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.

Please see full Prescribing Information and Patient Information.

  1. References:
  2. 1. STENDRA Prescribing Information. Cranford, NJ: Mist Pharmaceuticals, LLC; 2018.
  3. 2. Goldstein I, McCullough AR, Jones LA, et al. A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction. J Sex Med. 2012;9(4):1122-1133.
  4. 3. Goldstein I, Jones LA, Belkoff LH, et al. Avanafil for the treatment of erectile dysfunction: a multicenter, randomized, double-blind study in men with diabetes mellitus. Mayo Clin Proc. 2012;87(9):843-852.