Resveratrol

Addyi is the first and only FDA-approved, hormone-free pill clinically proven to treat low sexual desire in women RALEIGH, N.C., July 24, 2025 /PRNewswire/ -- Sprout Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemental application to expand the indication of Addyi® (flibanserin 100mg), the first and only FDA-approved pill for low sexual desire in women, to also include women who have gone through menopause. Continue Reading Addyi® (flibanserin) is the #1 prescribed treatment for Hypoactive Sexual Desire Disorder (HSDD). This marks a potential pivotal advancement in women's sexual health, addressing a long-standing unmet need for millions of women experiencing hypoactive sexual desire disorder (HSDD). While nearly 40% of women will experience low sexual desire at some point in their lives, women beyond their reproductive years still do not have a single FDA approved medical treatment option. "This isn't just a regulatory milestone — it's cultural recognition," said Cindy Eckert, Founder and CEO of Sprout Pharmaceuticals. "Sexual desire is ageless. Access to care should be too. Priority Review brings us closer to expanding access and empowering more women with a science-backed, FDA approved solution for their sexual wellness." The FDA's Priority Review designation is reserved for drugs that offer significant improvements in treatment for serious unmet medical needs. With enhanced focus and tighter timelines granted by the Agency, this designation underscores the urgency and importance of closing the gap in women's sexual healthcare. Following the FDA's recent public meeting on removing outdated estrogen labeling, Addyi's Priority Review reflects the same urgency and momentum signaling the Agency's commitment to ensuring that women at every life stage receive evidence-based care grounded accurately with the current science and focused on improving their quality of life. Backed by the largest clinical trials in women's sexual health, Addyi originally received FDA approval for premenopausal women. After reviewing its robust safety and efficacy profile, Health Canada also approved Addyi with expanded use in women that have gone through menopause. Now the FDA has the data to potentially do the same. "This is about expanding access, expanding awareness, and expanding agency for women who have been overlooked for far too long," Eckert added. If approved, the updated Addyi label will mark a major shift toward inclusive, life-stage-spanning innovation in sexual health, recognizing that women deserve options no matter their age. About Sprout Pharmaceuticals Sprout Pharmaceuticals is leading a revolution in women's health, pioneering innovative treatments that address long-overlooked needs. With the launch of Addyi, the first and only FDA-approved pill to treat low sexual desire (HSDD), Sprout helped shift the conversation around women's sexual wellness. The company remains committed to advancing science, expanding access, and advocating for the care women deserve. About Addyi ® (flibanserin) Addyi is the first and only FDA-approved pill to treat low libido (HSDD) in certain premenopausal women. Addyi is a non-hormonal medication, prescribed by over 25,000 U.S. healthcare professionals and growing. Addyi works on key neurotransmitters that affect sexual response. Before taking Addyi, you should consult with your doctor about all your medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Learn more at addyi.com About Hypoactive Sexual Desire Disorder (HSDD) Hypoactive Sexual Desire Disorder (HSDD), also known as frustrating low libido, is a persistent lack of sexual interest or desire. It is the most common form of sexual dysfunction in women, impacting an estimated 40% of women according to the Mayo Clinic. IMPORTANT SAFETY INFORMATION What is the most important information I should know about ADDYI? Your risk of severe low blood pressure and fainting (loss of consciousness) is increased: if you drink alcohol close to the time you take your ADDYI dose, if you take ADDYI with certain medicines, or if you have liver problems and you take ADDYI. To lower your risk of low blood pressure and fainting (loss of consciousness): Do not drink alcohol close to the time you take your ADDYI dose Wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks before taking ADDYI at bedtime. Skip your ADDYI dose if you drink 3 or more standard alcoholic drinks that evening. After taking ADDYI at bedtime do not drink alcohol until the following day. Examples of 1 standard alcoholic drink include: one 12-ounce regular beer 5 ounces of wine 1.5 ounces of distilled spirits or shot Tell your doctor about other medicines you take. Do not take or start taking any prescription or over-the-counter medicines, or herbal supplements without first talking to your doctor. Your doctor will tell you if it is safe to take other medicines or herbal supplements while you are taking ADDYI. Do not take ADDYI if you have liver problems. If you take ADDYI and you feel lightheaded or dizzy, lie down right away. Get emergency medical help or ask someone to get emergency medical help for you if the symptoms do not go away or if you feel like you could faint (lose consciousness). If you faint, tell your doctor as soon as you can. Who should not take ADDYI? Do not take ADDYI if you: take certain medicines. Taking ADDYI with certain other medicines can increase the amount of ADDYI in your blood and cause severe low blood pressure, fainting (loss of consciousness), and sleepiness. Do not take ADDYI if you are taking any of the following medicines: Certain medicines used to treat HIV-1 infection Certain medicines that you take by mouth used to treat fungal infections Certain antibiotics Certain medicines used to treat Hepatitis C infection Certain medicines used to treat high blood pressure, chest pain (angina), or other heart problems Nefazodone: a medicine used to treat depression Ask your doctor or pharmacist if you are not sure if you take any of the medicines listed above. These are examples of the medicines that you should not take if you are taking ADDYI. Tell your doctor about all the medicines you take before you start taking ADDYI have liver problems are allergic to flibanserin or any of the ingredients in ADDYI. See Medication Guide for the full list of ingredients. What should I tell my doctor before taking ADDYI? Before you take ADDYI, tell your doctor about all of your medical conditions, including if you: drink alcohol, use drugs, or have a history of alcohol or drug abuse have ever had depression or other mental health problems have low blood pressure or a medical condition that can cause low blood pressure are pregnant or plan to become pregnant. It is not known if ADDYI will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ADDYI passes into your breast milk. You and your doctor should decide if you will take ADDYI or breastfeed. You should not do both. Tell your doctor if you have had an allergic reaction such as hives, itching, or trouble breathing during or after receiving a dose of ADDYI. Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ADDYI can affect the way other medicines work, and other medicines can affect the way ADDYI works, and can cause serious side effects. What should I avoid while taking ADDYI? Do not drink alcohol close to the time you take your ADDYI dose because this increases your risk of severe low blood pressure and fainting (loss of consciousness). Do not drive, operate machinery, or do things that require clear thinking until at least 6 hours after you take ADDYI and until you know how ADDYI affects you. Do not drink grapefruit juice if you take ADDYI. Drinking grapefruit juice during your treatment with ADDYI increases your risk of severe low blood pressure and fainting (loss of consciousness). You should not take the herbal supplements St. John's Wort, ginkgo, or resveratrol or certain over-the-counter medicines such as cimetidine until you talk to your doctor. Taking ADDYI with these herbal supplements and over-the-counter medicines may increase your risk of low blood pressure, fainting (loss of consciousness), and sleepiness. What are the possible side effects of ADDYI? ADDYI can cause serious side effects, including: Sleepiness is a common side effect of ADDYI and can be serious. Taking ADDYI can increase your risk of sleepiness if taken during waking hours, if you drink alcohol, or take certain medicines or herbal supplements. Low blood pressure and fainting (loss of consciousness) can happen when you take ADDYI even if you do not drink alcohol or take other medicines or herbal supplements. Your risk of low blood pressure and fainting (loss of consciousness) is increased if ADDYI is taken during waking hours, if you drink alcohol within 2 hours of taking ADDYI, or if you take certain medicines or herbal supplements. The most common side effects of ADDYI include: Dizziness Difficulty falling asleep or staying asleep Nausea Dry mouth Tiredness These are not all of the possible side effects of ADDYI. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. See full Prescribing Information, including Boxed Warning regarding severe low blood pressure and fainting in certain settings, and Medication Guide at addyi.com/pi. This information does not take the place of talking with your doctor. INDICATION What is ADDYI (add-ee) (flibanserin) Tablets? ADDYI is a prescription medicine used to treat hypoactive (low) sexual desire disorder (HSDD) in women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner. Women with HSDD have low sexual desire that is troubling to them. Their low sexual desire is not due to: a medical or mental health problem problems in the relationship medicine or other drug use. ADDYI is not for use for the treatment of HSDD in women who have gone through menopause, in men or in children. ADDYI is not for use to improve sexual performance. SOURCE Sprout Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Transforming a promising molecule into a clinically viable therapeutic platform Jupiter, Florida, July 23, 2025 (GLOBE NEWSWIRE) -- Jupiter Neurosciences, Inc. (NASDAQ: JUNS) ("Jupiter" or the "Company"), a clinical-stage pharmaceutical company developing JOTROL™, a patented resveratrol-based platform, spotlights the scientific and clinical advantages of its proprietary resveratrol platform, JOTROL™, over conventional resveratrol formulations. Unlocking Resveratrol’s Therapeutic Promise Resveratrol is one of the world’s most researched molecules and has long been studied for its powerful antioxidant, mitochondrial, and anti-inflammatory effects. However, achieving therapeutic benefit has proven elusive due to the molecule’s extremely poor bioavailability and dose-limiting gastrointestinal (GI) side effects. “Clinical studies have shown that to reach the minimum effective plasma concentration of over 250 ng/mL a patient would need to ingest approximately 5 grams of today’s marketed resveratrol products,” explained Christer Rosén, Chairman and CEO of Jupiter Neurosciences. “At those levels, severe GI issues are nearly guaranteed, effectively halting any realistic therapeutic use.” A Pharmaceutical-Grade Breakthrough JOTROL™ was developed specifically to overcome these critical limitations. In a Phase I clinical trial, JOTROL™ achieved a nine-fold increase in bioavailability compared to traditional resveratrol, without the GI toxicity seen at high doses. This proprietary formulation enables systemic therapeutic dosing with significantly reduced pill burden and enhanced tolerability. Key Differentiators: Approximately 9 times higher bioavailability at peak plasma concentration versus naïve resveratrolNo GI side effects observed at therapeutic levelsSecured intellectual property in the U.S., EU, China, Japan, and Hong Kong through 2036Demonstrated ability to reach the central nervous system by passing the blood brain barrier, a critical factor for diseases such as Parkinson’s, Alzheimer’s, and MELAS A Platform for Clinical Development and Commercial Growth JOTROL™ is currently advancing toward a Phase IIa trial in Parkinson’s Disease, following breakthrough preclinical data in a well-established MPTP mouse model that demonstrated meaningful improvements in motor functions. The same delivery technology is also being used in Jupiter’s Nugevia™ consumer product line, launching in Q3 2025 with targeted formulations focused on cognitive health (MND), mitochondrial energy (PWR), and skin vitality (GLO). “This is more than just a formulation. It’s a platform,” added Rosén. “Whether through pharmaceutical trials or premium consumer offerings, JOTROL™ opens entirely new pathways to address CNS diseases and longevity using the same foundational science.” Scientific Rationale: Targeting Mitochondria and Inflammation As shown in Jupiter’s preclinical and mechanistic studies, resveratrol, and by extension JOTROL™, works by promoting mitochondrial biogenesis through AMPK and SIRT1 activation. It also scavenges oxidative radicals and suppresses neuroinflammation. These mechanisms are increasingly recognized as central to the progression of neurodegenerative disease and systemic aging. About Jupiter Neurosciences, Inc. Jupiter Neurosciences is a clinical-stage pharmaceutical company pursuing a dual-path strategy to address neuroinflammation and promote healthy aging. The Company is advancing a therapeutic pipeline targeting central nervous system (CNS) disorders and rare diseases, while also expanding into the consumer longevity market with its Nugevia™ product line. Both efforts are powered by JOTROL™, Jupiter’s proprietary, enhanced resveratrol formulation that has demonstrated significantly improved bioavailability. Nugevia brings clinical-grade science to the supplement space, supporting mental clarity, skin health, and mitochondrial function. The Company’s prescription pipeline is focused broadly on CNS disorders, presently with a Phase IIa in Parkinson’s disease, includeing indications such as Alzheimer’s Disease, Mucopolysaccharidoses Type I, Friedreich’s Ataxia, and MELAS. More information may be found on the Company’s website www.jupiterneurosciences.com. About JOTROL Resveratrol is one of the world’s most extensively researched molecules. Thorough evaluation has shown that for the compound to be effective, it requires a high C-Max (~300 ng/ml of resveratrol in plasma), achievable only with doses exceeding 3 grams using earlier resveratrol products. Poor bioavailability has been a well-documented issue with resveratrol. Doses over 2 grams have been associated with severe gastrointestinal (GI) side effects, which have prevented the compound from receiving regulatory approval for any indication. Jupiter Neurosciences (JUNS) conducted a Phase I study demonstrating that JOTROL™ achieves over nine times higher bioavailability compared to resveratrol used in earlier clinical trials (e.g., Turner et al., MCI/Early Alzheimer’s Disease trial, and Yui et al., Friedreich’s Ataxia trial). The results of this Phase I study, which will be cross-referenced in all upcoming JOTROL™ trials, were published in the Journal of Alzheimer’s Disease and AAPS Open in February 2022. JUNS is now advancing JOTROL™ toward a Phase IIa trial in Parkinson’s Disease. About Nugevia In addition to its therapeutic applications, JOTROL™ serves as the foundation for Jupiter’s Nugevia™ consumer supplement line. By leveraging the same clinically validated delivery technology, Nugevia™ introduces pharmaceutical-grade bioavailability into the wellness space, offering targeted support for cognitive health, skin vitality, and cellular energy. The Nugevia product line will be launched in Q3 of 2025 through the website Nugevia.com. FORWARD-LOOKING STATEMENTS Certain statements in this announcement are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations, including the Company’s ability to generate revenues from the sale of JOTROL products to consumers through the DTC model. Investors can find many (but not all) of these statements by the use of words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct. The Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to read the risk factors contained in the Company’s final prospectus and other reports it files with the SEC before making any investment decisions regarding the Company’s securities. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Contact: Dave GentryRedChip Companies, Inc.1-407-644-42561-800-RED-CHIP (733-2447)JUNS@redchip.com