Data Published in the "International Journal of Urology" Also Showed Secondary Endpoints, Such as Onset of action in 15 Minutes and Percentage of Patients Reaching Normal Erectile Function According to the IIEF-EF Score
NEW YORK, NY / ACCESSWIRE / September 8, 2022 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a leading provider of therapeutics for men's health, today announces newly published third party data in the International Journal of Urology Efficacy and safety of avanafil as compared with sildenafil in the treatment of erectile dysfunction by Kumar, Pathade, Gupta, Goyal, Rath, Thakre, Sanmukhani, and Mittal, detailing the Company's PDE 5 inhibitor STENDRA® (avanafil) tablets in a non-inferiority, head-to-head study compared to sildenafil (Viagra) which was conducted in India. The primary efficacy endpoint was improvement in erectile function based on domain score of the International Index of Erectile Function (IIEF). Some secondary endpoints included, the percentage of patients reaching a normal IIEF-EF score; percentage of successful vaginal penetrations and successful intercourse in the two groups; and percentage of doses with some erection in 15 mins in the two groups. The Zydus Healthcare-sponsored study, also showed rapid onset of action of STENDRA as demonstrated by a questionnaire determining whether some erection occurred within 15 minutes of dosing (see important safety information below).
"The results of this study are important for men's health as data demonstrated STENDRA, the latest entry into a long-standing ED oral administration category, provides men with a significant therapeutic option.," said Fady Boctor, Petros Pharmaceuticals' President and Chief Commercial Officer. "We believe that this study provides reason to approach Zydus Healthcare and the FDA to explore additional options. At minimum, this study aligns with and continues to confirm the results of the pivotal, clinical trials, demonstrating that STENDRA® provides significant therapeutic value-- particularly regarding satisfactory sexual function and onset of action within 15 minutes (100mg). This is critical reinforcement for STENDRA as a prescription therapy today, but also for its relevance as a potential Over the Counter (OTC) therapy in the future."
In the prospective, randomized, double-blind, two-arm, active controlled parallel, multicenter, non-inferiority clinical study, 220 men diagnosed with erectile dysfunction for at least three months and an IIEF domain score of less than 26, majority were considered moderate to severe with their ED. The mean age of patients was 36.4 with a history of ED for about 8 months, and they were randomized to receive either STENDRA® (avanafil) 100 mg, or sildenafil 50 mg in a 1:1 ratio for 12 weeks. The number of doses and attempts at sexual intercourse ranged from four to 20 in the avanafil group and four to 16 in the sildenafil group during any 4-week interval between the visits. Both groups required dose escalation after four weeks of study treatment (41 of 108 avanafil patients, or 40% compared to 47 of 103 of sildenafil patients or 47%). In terms of efficacy, IIEF-EF scores increased compared to baseline for both groups, with a marked difference beginning at week 4. Erectile function scores from baseline changed from week four, where there was score difference of 1.1 (0.2 to 2.5,) between avanafil and sildenafil. Week 8 showed a score difference of 1.4 (0.1 to 2.7), and Week 12 showed a difference of 2.1 (0.8 to 3.5,). In addition, after 12 weeks of treatment, 64.8% of avanafil patients scored "normal" for erectile function on the IIEF compared to 36.9% of sildenafil patients.
Consistent with pivotal trials for the class, the study also utilized the standard sexual encounter profile (SEP) questions to determine successful intercourse. At all three follow-up points, avanafil was compared to sildenafil (modified SEP 1 some erection within 15 minutes; SEP 2 successful vaginal penetration; SEP 3 successful intercourse). Of particular note, at 12 weeks, avanafil was compared to sildenafil in both onset of 15 minutes or less (84.8% vs. 28.2%), successful intercourse (75.1% vs. 68%) and vaginal penetration (87% vs. 81.4%).
Both compounds were well tolerated by all patients in the study, with a total of 13 adverse events reported in 11 patients in the avanafil group, and 13 adverse events in 12 patients in the sildenafil group. Most adverse events in both groups were reported as "mild," with headache being the most commonly reported.
Some limitations to the study include small sample size and insufficient powering to detect significant differences in safety profiles in addition to using subjective parameters to compare the efficacy of the two drugs. It is important to note the non-inferiority trial design is not intended to show one product is better than another. The study was also conducted in Indian patients and had a patient population that was younger than what was included in the pivotal trials. The authors recommend carrying out further studies to compare the efficacy of avanafil with other PDE inhibitors in patients with ED and also compare its effect with other PDE5 inhibitors in patients associated with comorbidities, such as diabetes, hypertension, cardiovascular disease, neurological disorders (such as spinal cord injury, multiple sclerosis), renal insufficiency and a history of urological pelvic surgery.
About STENDRA® (avanafil)
Stendra® (avanafil), originally launched by Auxilium Pharmaceuticals prior to that company's sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE-5) inhibitor for the treatment of erectile dysfunction. STENDRA is not for use in women or children under 18 years of age. (A 100-mg and 200-mg tablet can be taken as early as ~15 minutes before sexual activity. STENDRA only works with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine or 3 shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, respectively, stopped taking STENDRA (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% on placebo. Stendra® was designed and developed expressly for erectile dysfunction. The Company recently undertook a relaunch of Stendra®, generating gross revenues of approximately $30 million in 2019. Petros intends to accelerate the relaunch of Stendra® with a well-funded commercial organization and refocused strategy.
STENDRA Important Risk Information
STENDRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.
Do not take STENDRA if you:
- take medicines called nitrates, which are used to treat chest pain (angina)
- use street drugs called "poppers," such as amyl nitrate and butyl nitrate
- take medicines called guanylate cyclase stimulators, which include Adempas® (riociguat), a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
- are allergic to avanafil or any of the ingredients in STENDRA
Stop sexual activity and get medical help right away if you have symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Discuss your health with your healthcare provider to ensure you are healthy enough for sex.
STENDRA can cause serious side effects.
Uncommonly reported side effects include:
- An erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away.
- Sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause vision loss. Stop taking STENDRA and call your healthcare provider right away if you have sudden vision loss in one or both eyes.
- Sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness.
Before you take STENDRA, tell your healthcare provider if you:
- have or have had heart problems such as a heart attack, irregular heartbeat, angina, or heart failure; have had heart surgery within the last 6 months; have had a stroke; have low blood pressure, or high blood pressure that is not controlled; have a deformed penis shape
- have had an erection that lasted for more than 4 hours; have problems with your blood cells, such as sickle cell anemia, multiple myeloma, or leukemia; have retinitis pigmentosa, a rare genetic (runs in families) eye disease; have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION); have bleeding problems; have or have had stomach ulcers; have liver problems; have kidney problems or are having kidney dialysis; or have any other medical conditions
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. STENDRA may affect the way other medicines work, and other medicines may affect the way STENDRA works, which may cause side effects. Especially tell your healthcare provider if you take any of the following:
- medicines called nitrates
- medicines called guanylate cyclase stimulators, such as riociguat
- medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir (Crixivan®), saquinavir (Fortavase® or Invirase®), or atazanavir (Reyataz®)
- some types of oral antifungal medicines, such as ketoconazole (Nizoral®) and itraconazole (Sporanox®)
- some types of antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin
- medicines called alpha-blockers. These include terazosin (Hytrin®), tamsulosin HCl (Flomax®), doxazosin (Cardura®), prazosin HCl (Minipress®), alfuzosin HCl (UroXatral®), dutasteride and tamsulosin HCl (Jalyn®), or silodosin (Rapaflo®). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of STENDRA with alpha-blockers can lead to a drop in blood pressure or fainting
- other medicines that treat high blood pressure
- other medicines or treatments for ED
Do not drink too much alcohol (for example, more than 3 glasses of wine or 3 shots of whiskey) when taking STENDRA, as this can lead to increased chances of headache, dizziness, increased heart rate, or lowered blood pressure.
STENDRA does not protect against sexually transmitted diseases, including HIV.
The most common side effects of STENDRA are headache, flushing, stuffy or runny nose, sore throat, and back pain.
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of STENDRA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.
STENDRA is a prescription medicine used to treat erectile dysfunction (ED). STENDRA is not for use in women or children. It is not known if STENDRA is safe and eﬀective in women or children under 18 years of age.
For more information about Stendra, call 844-458-4887. If you would like to report an adverse event or product compliant, please contact us at 844-458-4887.
You are encouraged to report adverse events related to prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
ABOUT PETROS PHARMACEUTICALS
Petros Pharmaceuticals is committed to the goal of becoming a world-leading specialized men's health company by identifying, developing, acquiring, and commercializing innovative therapeutics for men's health issues including, but not limited to erectile dysfunction, endothelial dysfunction, psychosexual and psychosocial ailments, Peyronie's disease, hormone health and substance use disorders.
This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as "plans", " expects" or "does not expect", "proposed", "is expected", "budgets", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the failure of the offering described in this press release to close; Petros Pharmaceuticals' ability to execute on its business strategy, including its plans to develop and commercialize its product candidates; Petros Pharmaceuticals' ability to comply with obligations as a public reporting company; the ability of Petros Pharmaceuticals to timely and effectively implement controls and procedures required by Section 404 of the Sarbanes-Oxley Act of 2002; the risk that the financial performance of Petros Pharmaceuticals may not be as anticipated by the merger transactions that resulted in Petros Pharmaceuticals' creation; risks resulting from Petros Pharmaceuticals' status as an emerging growth company, including that reduced disclosure requirements may make shares of Petros Pharmaceuticals common stock less attractive to investors; risks related to Petros Pharmaceuticals' history of incurring significant losses; risks related to Petros Pharmaceuticals' dependence on the commercialization of a single product, Stendra®, and on a single distributor thereof; risks related to Petros Pharmaceuticals' ability to obtain sufficient quantities of Stendra® in a timely manner or on commercially viable terms; risks related to Petros Pharmaceuticals' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates; and the expected or potential impact of the novel coronavirus pandemic, including the emergence of new variants, such as the Delta variant, and the related responses of governments, consumers, customers, suppliers, employees and Petros Pharmaceuticals, on Petros Pharmaceuticals' business, operations, employees, financial condition and results of operations. A discussion of these and other factors, including risks and uncertainties with respect to Petros Pharmaceuticals, and other factors described in Petros Pharmaceuticals' most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the Securities and Exchange Commission, which can be reviewed at www.sec.gov. Petros Pharmaceuticals disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
SOURCE: Petros Pharmaceuticals, Inc.
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