NEW YORK, Jan. 24, 2022 /PRNewswire/ — Petros Prescription drugs, Inc. (“Petros” or “the Firm”) (Nasdaq: PTPI), a number one supplier of therapeutics for males’s well being, in the present day broadcasts it has partnered with a number one Contract Improvement and Manufacturing Group (CDMO), for industrial manufacturing of STENDRA (avanafil) tablets. The brand new partnership, which replaces a earlier settlement with Vivus, will switch manufacturing of the product to the US, and is predicted to supply each value financial savings and improve in gross margin.
“The CDMO, was chosen for this vital expertise switch and ongoing provide of STENDRA primarily based on its fame of excellence, sturdy proficiencies, and extremely responsive customer support. With anticipated enhancements leading to home manufacturing of STENDRA within the US and an estimated discount in our COGs, we’re on path with this new companion to strengthen our gross revenue margins accordingly. Finally, on this settlement we’re assured our provide chain shall be enormously enhanced on quite a few fronts.”
About STENDRA® (avanafil)
STENDRA® (avanafil), initially launched by Auxilium Prescription drugs previous to that firm’s sale to Endo Prescription drugs, is an oral phosphodiesterase 5 (PDE5) inhibitor for the therapy of erectile dysfunction. STENDRA® isn’t to be used in girls or kids. It isn’t identified if STENDRA® is secure and efficient in girls or kids underneath 18 years of age. 100-mg and 200-mg tablets will be taken as early as ~quarter-hour earlier than sexual exercise. STENDRA® works solely with sexual stimulation and shouldn’t be taken greater than as soon as a day. STENDRA® will be taken with or with out meals; don’t drink an excessive amount of alcohol when taking STENDRA® (for instance, greater than 3 glasses of wine or 3 photographs of whiskey) as it will possibly improve probabilities of negative effects. Of individuals enrolled in medical trials, 1.4%, 2.0%, and a pair of.0%, stopped taking STENDRA® (50 mg, 100 mg, or 200 mg, respectively) attributable to negative effects in comparison with 1.7% on placebo. STENDRA® was designed and developed expressly for erectile dysfunction. Presently, STENDRA® is roofed for ~75% of commercially insured lives, with a co-pay as little as $0. For extra info go to: https://STENDRA.com/.
STENDRA® Necessary Danger Info
STENDRA® may cause your blood strain to drop all of a sudden to an unsafe degree whether it is taken with sure different medicines. A sudden drop in blood strain may cause you to really feel dizzy, faint, or have a coronary heart assault or stroke.
Don’t take STENDRA® should you:
- take medicines known as nitrates, that are used to deal with chest ache (angina)
- use road medicine known as “poppers,” equivalent to amyl nitrate and butyl nitrate
- take medicines known as guanylate cyclase stimulators, which embrace Adempas® (riociguat), a drugs that treats pulmonary arterial hypertension and persistent thromboembolic pulmonary hypertension
- are allergic to avanafil or any of the substances in STENDRA®
Cease sexual exercise and get medical assist straight away you probably have signs equivalent to chest ache, dizziness, or nausea throughout intercourse. Sexual exercise can put an additional pressure in your coronary heart, particularly in case your coronary heart is already weak from a coronary heart assault or coronary heart illness. Talk about your well being along with your healthcare supplier to make sure you are wholesome sufficient for intercourse.
STENDRA® may cause critical negative effects.
Uncommonly reported negative effects embrace:
- An erection that won’t go away (priapism). If in case you have an erection that lasts greater than 4 hours, get medical assist straight away.
- Sudden imaginative and prescient loss in a single or each eyes. Sudden imaginative and prescient loss in a single or each eyes is usually a signal of a critical eye drawback known as non-arteritic anterior ischemic optic neuropathy (NAION). It’s unsure whether or not PDE5 inhibitors straight trigger imaginative and prescient loss. Cease taking STENDRA® and name your healthcare supplier straight away you probably have sudden imaginative and prescient loss in a single or each eyes.
- Sudden listening to lower or listening to loss. Some individuals may have ringing of their ears (tinnitus) or dizziness.
Earlier than you are taking STENDRA®, inform your healthcare supplier should you:
- have or have had coronary heart issues equivalent to a coronary heart assault, irregular heartbeat, angina, or coronary heart failure; have had coronary heart surgical procedure inside the final 6 months; have had a stroke; have low blood strain, or hypertension that isn’t managed; have a deformed penis form
- have had an erection that lasted for greater than 4 hours; have issues along with your blood cells, equivalent to sickle cell anemia, a number of myeloma, or leukemia; have retinitis pigmentosa, a uncommon genetic (runs in households) eye illness; have ever had extreme imaginative and prescient loss, together with a watch drawback known as non-arteritic anterior ischemic optic neuropathy (NAION); have bleeding issues; have or have had abdomen ulcers; have liver issues; have kidney issues or are having kidney dialysis; or have every other medical situations
Inform your healthcare supplier about all the medicines you are taking, together with prescription and nonprescription medicines, nutritional vitamins, and natural dietary supplements. STENDRA® might have an effect on the way in which different medicines work, and different medicines might have an effect on the way in which STENDRA® works, which can trigger negative effects. Particularly inform your healthcare supplier should you take any of the next:
- medicines known as nitrates
- medicines known as guanylate cyclase stimulators, equivalent to riociguat
- medicines known as HIV protease inhibitors, equivalent to ritonavir (Norvir®), indinavir (Crixivan®), saquinavir (Fortavase® or Invirase®), or atazanavir (Reyataz®)
- some forms of oral antifungal medicines, equivalent to ketoconazole (Nizoral®) and itraconazole (Sporanox®)
- some forms of antibiotics, equivalent to clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin
- medicines known as alpha-blockers. These embrace terazosin (Hytrin®), tamsulosin HCl (Flomax®), doxazosin (Cardura®), prazosin HCl (Minipress®), alfuzosin HCl (UroXatral®), dutasteride and tamsulosin HCl (Jalyn®), or silodosin (Rapaflo®). Alpha-blockers are generally prescribed for prostate issues or hypertension. In some sufferers, using STENDRA® with alpha-blockers can result in a drop in blood strain or fainting
- different medicines that deal with hypertension
- different medicines or remedies for ED
Don’t drink an excessive amount of alcohol (for instance, greater than 3 glasses of wine or 3 photographs of whiskey) when taking STENDRA®, as this may result in elevated probabilities of headache, dizziness, elevated coronary heart fee, or lowered blood strain.
STENDRA® doesn’t shield towards sexually transmitted illnesses, together with HIV.
The commonest negative effects of STENDRA® are headache, flushing, stuffy or runny nostril, sore throat, and again ache.
Inform your healthcare supplier you probably have any facet impact that bothers you or doesn’t go away. These usually are not all the doable negative effects of STENDRA®. For extra info, ask your healthcare supplier or pharmacist. Name your healthcare supplier for medical recommendation about negative effects.
You might be inspired to report adversarial occasions associated to prescribed drugs to the FDA.
Go to www.fda.gov/medwatch or name 1-800-FDA-1088.
Please see full Prescribing Information and Patient Information.
About Petros Prescription drugs
Petros Prescription drugs is dedicated to the purpose of turning into a world-leading specialised males’s well being firm by figuring out, growing, buying, and commercializing modern therapeutics for males’s well being points, together with, however not restricted to, erectile dysfunction, endothelial dysfunction, psychosexual and psychosocial illnesses, Peyronie’s illness, hormone well being, and substance use problems.
Cautionary Word Relating to Ahead-Trying Statements
This press launch contains forward-looking statements inside the which means of Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Alternate Act of 1934, as amended. These forward-looking statements are primarily based upon Petros Prescription drugs, Inc.’s (“Petros,” “we,” “our,” “us” or the “Firm”) administration’s assumptions, expectations, projections, intentions and beliefs about future occasions. In some circumstances, predictive, future-tense or forward-looking phrases equivalent to “intend,” “develop,” “purpose,” “plan,” “predict”, “might,” “will,” “venture,” “estimate,” “anticipate,” “imagine,” “count on,” “proceed,” “potential,” “alternative,” “forecast,” “ought to” and related expressions, whether or not within the unfavorable or affirmative, are supposed to establish forward-looking statements, however usually are not the unique technique of figuring out such statements. Precise outcomes and the timing of sure occasions and circumstances might differ materially from these described by the forward-looking statements on account of dangers and uncertainties, together with, with out limitation, Petros’ potential to execute on its enterprise technique, together with its plans to develop and commercialize its product candidates; Petros’ potential to adjust to obligations as a public reporting firm; the power of Petros to well timed and successfully implement controls and procedures required by Part 404 of the Sarbanes-Oxley Act of 2002; the chance that the monetary efficiency of Petros is probably not as anticipated by the merger transactions that resulted within the Firm’s creation; dangers ensuing from Petros’ standing as an rising progress firm, together with that lowered disclosure necessities might make shares of Petros frequent inventory much less enticing to buyers; dangers associated to Petros’ historical past of incurring vital losses; dangers associated to Petros’ dependence on the commercialization of a single product, STENDRA®, and on a single distributor thereof; dangers associated to the termination of Petros’ industrial provide settlement with Vivus, together with the chance that Petros might not be capable to get hold of enough portions of STENDRA® in a well timed method or on commercially viable phrases; dangers associated to Petros’ potential to acquire regulatory approvals for, or market acceptance of, any of its merchandise or product candidates; and the anticipated or potential influence of the novel coronavirus (“COVID-19”) pandemic, together with the emergence of recent variants, such because the Delta variant, and the associated responses of governments, shoppers, clients, suppliers, staff and the Firm, on our enterprise, operations, staff, monetary situation and outcomes of operations. Extra components that might trigger precise outcomes to vary materially from the outcomes anticipated in these forward-looking statements are contained within the Firm’s periodic experiences and in different filings that the Firm has filed, or might file, with the U.S. Securities and Alternate Fee (the “SEC”) underneath the headings “Danger Components” and “Administration’s Dialogue and Evaluation of Monetary Situation and Outcomes of Operations” and elsewhere. The Firm cautions readers that the forward-looking statements included on this press launch signify our beliefs, expectations, estimates and assumptions solely as of the date of hereof and usually are not supposed to provide any assurance as to future outcomes. New components emerge now and again, and it’s not doable for us to foretell all of those components. Additional, the Firm can not assess the impact of every such issue on our enterprise or the extent to which any issue, or mixture of things, might trigger precise outcomes to be materially totally different from these contained in any forward-looking assertion. Accordingly, you shouldn’t unduly depend on any forward-looking statements.
The Firm undertakes no obligation to replace or revise any forward-looking statements contained on this press launch, whether or not on account of new info, future occasions, a change in our views or expectations or in any other case, besides as required by federal securities legal guidelines.
View unique content material:https://www.prnewswire.com/news-releases/petros-pharmaceuticals-partners-with-leading-global-contract-manufacturer-to-bring-production-of-erectile-dysfunction-drug-stendrao-avanafil-to-the-united-states-301466260.html
SOURCE Petros Prescription drugs, Inc.
