NEW YORK, Nov. 3, 2021 /PRNewswire/ -- Petros
Pharmaceuticals, Inc. (Petros, Nasdaq: PTPI), a leading provider of
therapeutics for men's health, today announces a 476% growth
year-over-year of STENDRA tablet sales as part of an exclusive
digital health marketing agreement with Hims & Hers Health,
Inc. ("Hims & Hers" or "Hims"), the multi-specialty telehealth
platform focused on providing modern personalized health and
wellness experiences to consumers. The companies also announce the
availability of additional dosages of STENDRA through the Hims
& Hers platform, further expanding the partnership.
"Our continued relationship with Hims supports an
industry-leading telehealth platform that
allows individuals to inquire about and address erectile
dysfunction with discretion and by way of a convenient method
of healthcare engagement," said Fady Boctor, Petros
Pharmaceuticals' President and Chief Commercial Officer. "With
significant growth year-over-year of STENDRA tablet sales
through Hims, we are excited to expand our collaboration with Hims
and enhance access to STENDRA through this critical
channel."
STENDRA is currently FDA-approved in 50mg, 100mg and 200mg
tablets, all of which are now accessible through the Hims
platform. Consumers looking to purchase any prescription
through Hims & Hers need to complete a virtual consultation
with a licensed healthcare provider via the platform to see if a
prescription treatment is medically recommended.
"Offering our customers access to STENDRA has helped to
strengthen our platform and achieve our mission of providing
greater access to personalized care," added Dr. Patrick Carroll, Chief Medical Officer at Hims
& Hers. "We are elated to be able to provide help and support
to the many people who experience erectile dysfunction. We look
forward to expanding our relationship with Petros by providing
more dosage options at affordable prices through our platform so
that even more people can access high quality,
personalized care."
"In our exclusive marketing agreement with Hims, Petros
continues to support the goal of destigmatizing the request for
this therapy and expanding overall engagement for treatment,"
concluded Mr. Boctor.
It is estimated that only about 25% of the approximately 30
million men suffering from erectile dysfunction in the U.S.
have received oral erectile dysfunction therapy.
About STENDRA (avanafil)
Stendra® (avanafil), originally launched by
Auxilium Pharmaceuticals prior to that company's sale to Endo
Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor
for the treatment of erectile dysfunction. 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. (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.
Please see full Prescribing
Information and Patient Information.
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.
Cautionary Note Regarding Forward-Looking
Statements
This press release includes forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. These forward-looking statements are based
upon Petros Pharmaceuticals, Inc.'s ("Petros," "we," "our," "us" or
the "Company") management's assumptions, expectations, projections,
intentions and beliefs about future events. In some cases,
predictive, future-tense or forward-looking words such as "intend,"
"develop," "goal," "plan," "may," "will," "project," "estimate,"
"anticipate," "believe," "expect," "continue," "potential,"
"opportunity," "forecast," "should" and similar expressions,
whether in the negative or affirmative, are intended to identify
forward-looking statements, but are not the exclusive means of
identifying such statements. Actual results and the timing of
certain events and circumstances may differ materially from those
described by the forward-looking statements as a result of risks
and uncertainties, including, without limitation, Petros' ability
to execute on its business strategy, including its plans to develop
and commercialize its product candidates; Petros' ability to comply
with obligations as a public reporting company; the ability of
Petros 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 may not be as anticipated
by the merger transactions that resulted in the Company's creation;
risks resulting from Petros' status as an emerging growth company,
including that reduced disclosure requirements may make shares of
Petros common stock less attractive to investors; risks related to
Petros' ability to continue as a going concern; risks related to
Petros' dependence on the commercialization of a single product,
Stendra®, and on a single distributor thereof; risks related to
Petros' commercial supply agreement with Vivus; and risks related
to Petros' ability to obtain regulatory approvals for, or market
acceptance of, any of its products or product candidates.
Additional factors that could cause actual results to differ
materially from the results anticipated in these forward-looking
statements are contained in the Company's periodic reports and in
other filings that the Company has filed, or may file, with the
U.S. Securities and Exchange Commission (the "SEC") under the
headings "Risk Factors" and "Management's Discussion and Analysis
of Financial Condition and Results of Operations" and elsewhere.
The Company cautions readers that the forward-looking statements
included in this press release represent our beliefs, expectations,
estimates and assumptions only as of the date of hereof and are not
intended to give any assurance as to future results. New factors
emerge from time to time, and it is not possible for us to predict
all of these factors. Further, the Company cannot assess the effect
of each such factor on our business or the extent to which any
factor, or combination of factors, may cause actual results to be
materially different from those contained in any forward-looking
statement. Accordingly, you should not unduly rely on any
forward-looking statements.
The Company undertakes no obligation to update or revise any
forward-looking statements contained in this press release, whether
as a result of new information, future events, a change in our
views or expectations or otherwise, except as required by federal
securities laws.
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SOURCE Petros Pharmaceuticals, Inc.