Petros Pharmaceuticals, Inc. (Nasdaq: PTPI), a leading
provider of therapeutics for men's health, today announces that it
has signed a compensated collaboration agreement with physician Dr.
Drew Pinsky (“Dr. Drew”) to raise awareness, foster dialogue,
educate, and alleviate the stigma of erectile dysfunction (ED) and
sexual dysfunction within the men’s health and wellness landscape.
Through this collaboration, Dr. Drew will expand awareness of
Petros Pharmaceuticals’ mission in the men’s health category and
provide greater education around its flagship pharmaceutical
therapy STENDRA (avanafil) especially as Petros continues to work
with the FDA to pursue Over The Counter (OTC) designation.
“Dr. Drew continues to be a key figure in educating the public
regarding sensitive health topics using his unique perspective and
public health platform. We believe this social media program will
help to further raise Petros’s profile in the men’s health
category, where we have dedicated our resources toward creating a
diversified offering of clinically supported options to health
problems unique to men, including erectile dysfunction and
Peyronie’s disease,” said Fady Boctor, Petros Pharmaceuticals'
President and Chief Commercial Officer. “We believe his emphasis on
the importance of patient self-care, and his ability to breathe new
life into hidden, ignored, or avoided issues, such as sexual and
erectile dysfunction, run parallel with our ongoing efforts to
increase patient access to STENDRA (avanafil), by pursuing OTC
designation as well as to increase its awareness among a population
looking for alternative options.”
As a public health advocate for topics long considered
sensitive, Dr. Drew’s influential opinions and perspectives should
help educate consumers about non-invasive treatment options
available for common conditions, which may include Petros’s ED
therapy STENDRA (avanafil) (see indications and important safety
information below), as well as its potential treatment under
development for Peyronie’s disease. It is estimated that more than
30 million men in the U.S. suffer from ED and despite more than 20
years since prescription solutions first became available for this
condition, roughly three out of every four sufferers remain
untreated 1,2. Peyronie’s disease, which impacts as many as one in
eleven men, is a connective tissue disorder of the penis that can
cause bent erections, erectile pain and scar tissue that creates
palpable penile lumps and/or penile curvature3.
“I am pleased to begin to discuss Petros Pharmaceuticals’
leadership on important men’s health topics, which have
consistently been difficult for men to discuss openly or
comfortably. Destigmatizing sensitive health issues – through open
and frank discussion - is paramount to self-care and enjoying good
overall health – for you and for your partner. I look forward to
showing my audience that they have an advocate to widen access to
treatment options that treat these difficult conditions,” added Dr.
Drew.
Dr. Drew has been a ubiquitous fixture both on television and
radio for the entirety of his multi-faceted career. With more than
two decades of syndicated celebrity voice as an acclaimed physician
and public health advocate, his long television resume includes
Loveline, Celebrity Rehab with Dr. Drew, and many others. He
represents the spirit of genuine transparency and dialogue --
especially around taboo topics that often burden individuals
experiencing them in silence or in isolation -- including sex,
substance abuse, and addiction. Dr. Drew has a considerable social
media following, with more than 2.6 million followers on Twitter,
more than 130,000 on Facebook and more than 45,000 subscribers to
his YouTube channel.
About Dr. Drew
Dr. Drew As a practicing internal medicine physician, addiction
specialist, and prolific broadcaster, Dr. Drew’s career has imbued
him with the rare ability to examine any issue through the lenses
of practical experience, scientific evidence, and pragmatism. He is
a two-time New York Times bestselling author, and a much
sought-after guest on the talk show and news circuits with multiple
appearances on Ellen, Oprah, Rachael Ray, The
View, Dr. Oz, Steve Harvey Show, Wendy
Williams, Jimmy Kimmel Live, Good
Morning America, Today Show, CNN and the Fox News
Channel.
- https://pubmed.ncbi.nlm.nih.gov/22240443/
-
https://consumer.healthday.com/men-s-health-information-24/male-hormones-health-news-389/most-men-with-erectile-dysfunction-don-t-seem-to-get-treatment-676114.html
-
https://www.hopkinsmedicine.org/health/conditions-and-diseases/peyronie-disease
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.
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.
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.
FORWARD-LOOKING STATEMENTS
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.
Investor ContactIR@PetrosPharma.com
Media:Jules AbrahamCORE
IR917-885-7378pr@coreir.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/ee4f5b6f-b8f1-4021-9f66-cb885f376cf5
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