HSDD

Palatin Provides Corporate Update and Highlights Strategic Priorities for Calendar Year 2024

Retrieved on: 
Monday, January 8, 2024
DED, HSDD, Probability, Sale, PDE5, Weight loss, UC, Trial of the century, PTN, Calendar, Obesity, Patient, Therapy, Female, Diabetic nephropathy, Erectile dysfunction, Pharmaceutical industry

"We made significant operational progress during calendar year 2023 and we believe we are well-positioned for making calendar year 2024 a pivotal and transformative year for Palatin," said Carl Spana, Ph.D., President and CEO of Palatin.

Key Points: 
  • "We made significant operational progress during calendar year 2023 and we believe we are well-positioned for making calendar year 2024 a pivotal and transformative year for Palatin," said Carl Spana, Ph.D., President and CEO of Palatin.
  • Topline data readout for our Phase 3 PL9643 clinical study for DED is expected early in the first quarter of calendar year 2024.
  • We expect to commence a Phase 2 clinical study of a MCR4 agonist plus a GLP-1 in obese patients in the first quarter of calendar year 2024.
  • The recently announced divestiture of Vyleesi is consistent with Palatin's strategic decision to concentrate on its robust development and clinical pipeline.

Cosette Pharmaceuticals Acquires Vyleesi® (Bremelanotide Injection) from Palatin Technologies Inc.

Retrieved on: 
Wednesday, January 3, 2024
Health, Consumer, Women, General Health, Pharmaceutical, Biotechnology, Patient, Orange Book, HSDD, Multimedia, Woman, Acquisition, Medication, Education, Bremelanotide, PTN, Female, Urology

Cosette Pharmaceuticals, Inc. (“Cosette”), a US-based specialty pharmaceutical company with a focus on women’s health and cardiovascular medicines, has completed the acquisition of Vyleesi® from Palatin Technologies, Inc. (NYSE: PTN), which includes 5 Orange Book listed patents with protection up to 2041.

Key Points: 
  • Cosette Pharmaceuticals, Inc. (“Cosette”), a US-based specialty pharmaceutical company with a focus on women’s health and cardiovascular medicines, has completed the acquisition of Vyleesi® from Palatin Technologies, Inc. (NYSE: PTN), which includes 5 Orange Book listed patents with protection up to 2041.
  • Palatin and Cosette will ensure continued patient and healthcare professional access to Vyleesi® throughout the transition period.
  • Cosette offers patients the ability to connect with a physician through a telemedicine option.
  • Patients and providers can learn more about HSDD and Vyleesi®, including Important Safety Information, at www.vyleesi.com .

Global Gynaecology Drugs Market Report 2023-2031: Tailoring Treatment Gaining Momentum - Explore the The Surge of Personalized Medicine in Gynecology - ResearchAndMarkets.com

Retrieved on: 
Thursday, September 7, 2023
Health, Pharmaceutical, Insurance, Acupuncture, Hypoactive sexual desire disorder, Prevalence, Education, Infection, FSAD, Woman, Research, Biomarker, Pelvic floor dysfunction, USD, Disorder, IVF, Patient, Fertility, Genetic testing, Diagnosis, HSDD, British Gynaecological Cancer Society, Female, Pharmaceutical industry, Birth control, Gynaecology

The "Global Gynaecology Drugs Market Report and Forecast 2023-2031" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Gynaecology Drugs Market Report and Forecast 2023-2031" report has been added to ResearchAndMarkets.com's offering.
  • The global gynaecology drugs market was valued at USD 26.9 billion in 2022, driven by the rising prevalence of gynaecological disorders across the globe.
  • The field of Gynaecology drugs is continuously evolving, driven by advancements in medical research, technology, and a better understanding of women's health.
  • Gynaecology drugs play a crucial role in the diagnosis, treatment, and management of various gynecological conditions and disorders.

Palatin's Vyleesi® Licensee Fosun Pharma Reports First Commercial Sale in China and South Korean Licensee Kwangdong Pharmaceuticals Completes Enrollment in Phase 3 Clinical Study

Retrieved on: 
Tuesday, August 8, 2023
PTN, Hypoactive sexual desire disorder, Fosun Pharma, Marketing, FTZ, MFDS, Woman, Prescription, Sale, Korean Ministry of Culture, Arousal, South Korea, Patient, HSDD, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Food, NMPA, Safety, Medical tourism, Pharmaceutical industry, Bremelanotide, Palatine, Fosun International

Palatin also announced that their South Korean licensee, Kwangdong Pharmaceuticals, completed enrollment in its Phase 3 clinical trial evaluating the efficacy and safety of Vyleesi in premenopausal women with HSDD.

Key Points: 
  • Palatin also announced that their South Korean licensee, Kwangdong Pharmaceuticals, completed enrollment in its Phase 3 clinical trial evaluating the efficacy and safety of Vyleesi in premenopausal women with HSDD.
  • Data from this trial is anticipated by year end with a potential regulatory submission in the first half of 2024.
  • "This first commercial sale, coupled with the completed enrollment in the Phase 3 clinical trial in South Korea, strengthens our position in the Asian marketplace.
  • In exchange, Palatin received an upfront payment of $500,000 and is due a $3.0 million milestone based on the first commercial sale in Korea.

Palatin Announces Direct-to-Consumer Telehealth Partnership with UpScriptHealth™ for Vyleesi®

Retrieved on: 
Monday, August 7, 2023
PTN, Telehealth, Partnership, Education, Woman, Patient, FDA, HSDD, Regulation of tobacco by the U.S. Food and Drug Administration, NYSE, Food, Female, Pharmaceutical industry, Bremelanotide

CRANBURY, N.J., Aug. 7, 2023 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced that it has entered a strategic partnership with UpScriptHealth, a leading direct-to-consumer telemedicine company providing telemedicine services to pharmaceutical and medical technology companies. Under terms of the agreement, UpScriptHealth will make Vyleesi available to the hundreds of thousands of patients in its proprietary Women's Telehealth Platform. Vyleesi is the first and only as-needed treatment approved by the U.S. Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).

Key Points: 
  • Under terms of the agreement, UpScriptHealth will make Vyleesi available to the hundreds of thousands of patients in its proprietary Women's Telehealth Platform.
  • Vyleesi is the first and only as-needed treatment approved by the U.S. Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).
  • "We are excited to partner with UpScriptHealth, a pioneer in telehealth," stated Carl Spana, Ph.D., President and Chief Executive Officer of Palatin.
  • "This partnership fortifies our existing telehealth programs and provides a platform to create greater awareness of HSDD and access to Vyleesi through UpScriptHealth's patient base of hundreds of thousands of women."

Daré Bioscience Announces Availability of Publication on the Patient-Centered Concept Elicitation Study for Female Sexual Arousal Disorder in The Journal of Sexual Medicine

Retrieved on: 
Wednesday, May 31, 2023
Cream, SST, Hypoactive sexual desire disorder, Female, Prevalence, Safety, Efficacy, PRO, Trial of the century, FSAD, Woman, Vasodilation, Arousal, Journal, Patient, Article, Erectile dysfunction, FDA, HSDD, ED, Medical imaging, Pharmaceutical industry, Birth control

SAN DIEGO, May 31, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced the publication of results of the patient-centered study designed to elucidate the commonly reported symptoms, including severity of symptoms, associated with female sexual arousal disorder (FSAD). The publication, “Symptoms and associated impact in pre-and postmenopausal women with sexual arousal disorder: a concept elicitation study,” appears in The Journal of Sexual Medicine.

Key Points: 
  • The publication, “Symptoms and associated impact in pre-and postmenopausal women with sexual arousal disorder: a concept elicitation study,” appears in The Journal of Sexual Medicine.
  • The non-interventional study was conducted to identify and document the genital arousal symptoms that are the most problematic and most important symptoms to treat for women with FSAD.
  • The content validity study included in-depth, qualitative, semi-structured concept elicitation interviews with premenopausal (n=23) and postmenopausal (n=13) women who were clinically diagnosed with FSAD by a trained sexual medicine clinician.
  • FSAD is distinct from hypoactive sexual desire disorder (HSDD) in women, which is characterized primarily by a lack of sexual desire.

Women's Pelvic Health: Top 10 Things Women Want to Know about Sex and Vaginal Health but Are Reluctant to Ask

Retrieved on: 
Tuesday, May 16, 2023
Hair, Correlates of crime, Female, Urinary tract infection, Orgasm, DSM-IV codes, Pain, Patient, Risk, Personal lubricant, Menopause, Prevalence, Pelvic floor, HSDD, Faught, SOLVE, Male, BV, Urine, Vaginal discharge, Urination, Fear, Ageing, Research, Vagina, Intrauterine device, Lubricant, Proanthocyanidin, Bacteria, System, Woman, Skin, WHNP-BC, Hypoactive sexual desire disorder, Emmanuele A. Jannini, Incontinence, Bacterial vaginosis, Vanderbilt University, NCMP, Arousal, International Society for the Study of Vulvovaginal Disease, Ejaculation, Burns, Distress, Obstetrics, Obstetrics and gynaecology, Infection, Libido, DNP, Nutritional science, Interstitial cystitis, Friction, PAC, Abrasion, Dry, Probiotic, Pelvic floor dysfunction, Urology, Wine, Nursing, Birth control, Via

ATLANTA, May 16, 2023 /PRNewswire/ -- Committed to helping healthcare providers elevate the care of women at midlife and beyond, Solv Wellness regularly hosts webinars that enable peer-to-peer knowledge sharing. During their latest free educational webinar for providers, Brooke Faught, DNP, WHNP-BC, NCMP, FAANP, IF, and member of the Solv Wellness medical advisory board, emphasized the importance of driving conversations about sex and pelvic health with their patients to ensure women are not suffering in silence, especially with the broad availability of safe and effective solutions.

Key Points: 
  • It's so important, and we can even identify a lot of serious health concerns based on sexual symptoms and sexual complications."
  • In the webinar, Dr. Faught covered a variety of often-ignored topics about women's pelvic health.
  • She hopes sharing her experience will help foster more open dialogue between patients and their healthcare providers during office visits.
  • First, it's important to determine what's causing lack of interest in sex: low libido or hypoactive sexual desire disorder (HSDD).

Oncotelic Reports Q3 2022 Compared to Q3 2021 Financial Results

Retrieved on: 
Monday, November 21, 2022
HSDD, Female, Cocaine, ED, Sertraline, Communication, PPP, Apomorphine, Food, Cancer, Hartmut Geerken, G&A, Mohammad Ali Allahdadi, Safety, Therapy, Melanoma, Orthostatic syncope, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CA4P, Optimism, Oxigen Services, Parkinson's disease, Disease, Fluoxetine, McMahon, Annual report, BARDA, Diffuse intrinsic pontine glioma, Male, Hypotension, PD, Research, Risk, BMJ, Ageing, PDE5, KJ, Circulatory system, Clinical trial, JV, Survival, Erectile dysfunction, Form 10-K, Woman, FSD, Manifest and latent functions and dysfunctions, Pharmaceutical industry, Bremelanotide

In comparing the Companys operating results for the three months ended September 30, 2022, and 2021, respectively, our net loss reduced by approximately $1.0 million.

Key Points: 
  • In comparing the Companys operating results for the three months ended September 30, 2022, and 2021, respectively, our net loss reduced by approximately $1.0 million.
  • Further, our general and administrative expenses decreased by approximately $0.6 million primarily due to reduced compensation expense of approximately $0.6 million.
  • We expect our R&D and G&A expense to remain steady or reduce for the remainder of the year 2022.
  • Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine.

Daré Bioscience Announces Subject Screening for Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder Complete

Retrieved on: 
Tuesday, November 1, 2022
Cream, Failure, Vulva, Arousal, CEO, Health, Potential, Menopause, PRO, Sex, SST, Sexual arousal disorder, SEC, GLOBE, 8-K, Health minister, Risk, COVID-19, Sexual desire, Intellectual property, Trial of the century, Fertility, Progesterone, Drug, FSAD, Organon, Safety, Vasodilation, ED, Form, NASDAQ, Social media, Investor, Review, Woman, FDA, Bacterial vaginosis, Patient, Man, Prevalence, Birth, RESPOND, Erectile dysfunction, Forward-looking statement, HSDD, Female, Vagina, Solution, Pharmaceutical industry, Sex industry, Birth control, Bayer

SAN DIEGO, Nov. 01, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced that subject screening for the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% is complete, allowing for a topline data announcement target of 2Q-2023. The Phase 2b RESPOND clinical study is a multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with female sexual arousal disorder (FSAD). A total of approximately 100 subjects have completed all study assessments to date and, based on the subjects that have completed screening, a total of approximately 160 to 170 subjects are expected to complete the study for inclusion in the topline data assessment targeted for 2Q-2023.

Key Points: 
  • The Phase 2b RESPOND clinical study is a multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with female sexual arousal disorder (FSAD).
  • Sildenafil Cream is a proprietary topical formulation of sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, being developed as a first-in-category option for the treatment of FSAD.
  • We look forward to evaluating the topline data next year, said Sabrina Martucci Johnson, President and CEO of Dar Bioscience.
  • Increasing blood flow to the genital tissue, as Sildenafil Cream is designed to do, has the potential to improve genital arousal response and overall sexual experience for women.

Daré Bioscience Announces Interim Analysis of Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder

Retrieved on: 
Monday, August 29, 2022
Cream, COVID-19, CEO, Safety, Female, Health minister, Bacterial vaginosis, SAN, SST, NASDAQ, Erectile dysfunction, Solution, Man, 8-K, ED, Vasodilation, Sex, Birth, SEC, Review, Menopause, Sexual desire, Progesterone, HSDD, GLOBE, Fertility, Prevalence, Vulva, FSAD, FDA, Arousal, Social media, PRO, RESPOND, Failure, Twitter, Form, Investor, Risk, Vagina, Organon, Intellectual property, Woman, Health, Sexual arousal disorder, Forward-looking statement, Trial of the century, Patient, Pharmaceutical industry, Sex industry, Birth control, Bayer

SAN DIEGO, Aug. 29, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced that, based on the results of an interim analysis to evaluate the relative magnitude of the treatment effect, they expect to complete enrollment in the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in 4Q-2022, allowing for a topline data announcement target of 2Q-2023. The interim analysis was conducted by an independent third-party statistical resource and both Daré and SST continue to remain blinded to results of the study by treatment group. The Phase 2b RESPOND clinical study is a multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with female sexual arousal disorder (FSAD).

Key Points: 
  • The interim analysis was conducted by an independent third-party statistical resource and both Dar and SST continue to remain blinded to results of the study by treatment group.
  • The Phase 2b RESPOND clinical study is a multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with female sexual arousal disorder (FSAD).
  • Completing this Phase 2b study will be a significant milestone in the development of what has the potential to be the first FDA-approved product to treat FSAD.
  • FSAD is distinct from hypoactive sexual desire disorder (HSDD) in women, which is characterized primarily by a lack of sexual desire.