Hypogonadism

Pharmaceutical company Tolmar has partnered with direct-to-consumer telehealth company UpScriptHealth to provide telehealth consultations for Jatenzo, an oral testosterone-replacement therapy (TRT) for adult men. Tolmar, which acquired Jatenzo in 2022, is positioning the TRT treatment as suited for patients who lack testosterone or have low testosterone levels due to hypogonadism or other medical conditions. The treatment protocol for patients seeking testosterone, including Jatenzo, includes a series of lab tests to determine whether testosterone is the correct treatment for the patient. Peter Ax, founder and CEO of UpScriptHealth, told MobiHealthNews that the streamlined digital experience lets patients connect with licensed providers to receive treatment and ongoing care management from home. "By making the entire process more accessible and convenient, we expect better adherence rates for patients receiving testosterone replacement therapy," he explained. He said the collaboration with Tolmar was representative of a broader shift in how treatments for complex conditions can reach more patients. "Patients increasingly expect healthcare to fit their lifestyle, not the other way around," Ax said. "There's growing recognition that telehealth can provide more consistent monitoring and support than traditional models." THE LARGER TREND UpScriptHealth has launched more than 50 partnerships with pharma and has been expanding into rare diseases and complex care models, including on-site diagnostic testing for esophageal cancer, infusion care and the coordination of care with Alternative Sites of Care. The company works in a complicated regulatory environment, having to comply with fifty state laws and various federal laws regarding the delivery of care, patient safety and privacy, steering and other areas of regulation. "Compliance is fundamental to everything we do at UpScriptHealth," Ax said. "We have prioritized adherence since its inception and helped shape many of the regulations now guiding the industry." He explained that patient safety and data privacy are paramount and that focusing on compliance is critical in building trust with patients and partners. "UpScriptHealth’s clinicians are not incentivized to write prescriptions or to encourage the use of a specific therapy," he said. The company also offers treatments for hair loss and erectile dysfunction, and Ax noted that men who historically avoided seeking treatment due to stigma or inconvenience are now actively engaging with their health through UpScriptHealth’s platform. "Our goal is to make UpScriptHealth the comprehensive digital home for men's health, where patients can access the full spectrum of care they need with the convenience they expect," Ax said. In July, Axena Health and UpScriptHealth partnered to offer women online consultations with UpScriptHealth providers. This allows them to receive prescriptions for Axena’s Leva Pelvic Health System. The company has teamed up with medical device companies, including Spark Biomedical, to provide telehealth for its FDA-cleared opioid-withdrawal wearable, and Lucid Diagnostics, to expand access to esophageal pre-cancer testing, while it also enables telehealth consultations for Spark Biomedical's Sparrow Ascent wearable.

The original FDA full approval decision date was 15 October, but this has been delayed. Credit: Tada Images via Shutterstock. Intercept Pharmaceuticals will have to keep waiting for a decision about Ocaliva (obeticholic acid) after the US Food and Drug Administration (FDA) has asked for more time to determine whether to grant the drug full approval. It’s been a rocky ride for the rare liver disease drug, and now its subsidiary is also facing delays despite the original Prescription Drug User Fee Act (PDUFA) date for the drug’s supplemental New Drug Application (sNDA) being on 15 October. The treatment is only available to primary biliary cholangitis (PBC) patients through accelerated approval in the US. The FDA did not provide a new anticipated action date, however, Intercept’s president Vivek Devaraj said: “We will continue to engage with the FDA regarding our pending application.” Bologna, Italy-based Alfasigma inherited the drug as part of its $794m acquisition of Intercept Pharmaceuticals in September 2023 and the company has continued operating as a subsidiary of Alfasigma. However, the treatment has faced a series of setbacks since its 2016 accelerated approval. In 2018, the FDA had to add a boxed warning after Ocaliva was being incorrectly dosed as a daily treatment, instead of a weekly treatment. A September 2024 FDA advisory committee (AdCom) recommended against full approval for Ocaliva by a 13-1 vote, concluding that confirmatory evidence did not verify the treatment provided clinical benefit. In a separate vote, panellists voted 10-1 that the benefits of Ocaliva did not outweigh its risks, with three abstentions. In the same month, the European Commission (EC) withdrew Ocaliva’s conditional marketing authorisation as a second-line treatment for patients with PBC. This followed a June recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use, which reassessed the benefit-risk profile of the drug. In a surprise decision just days later, the President of the General Court of the European Union overruled the decision, allowing Ocaliva to remain on the market. See Also: Testosterone by M et P Pharma for Male Hypogonadism: Likelihood of Approval Integrin Alpha M drugs in development, 2024 PBC is a chronic autoimmune disease where the immune system attacks the small bile ducts in the liver, causing bile buildup, liver inflammation, and eventually scarring or cirrhosis. Ocaliva activates the farnesoid X receptor (FXR) to reduce bile acid production and promote its removal. Ocaliva now faces competition in the PBC space. In August 2024, the FDA granted accelerated approval to Gilead’s Livdelzi (seladelpar), a drug it inherited as part of the $4.3bn CymaBay Therapeutics deal in March 2024. According to GlobalData forecasts, Livdelzi is set to generate $558m in 2030. Before it was acquired by Alfasigma, Ocaliva earned $285.7m in 2022, as per Intercept’s financials. GlobalData is the parent company of Pharmaceutical Technology. In September 2024, the EC gave Ipsen’s Iqirvo (elafibranor) the green light for the treatment of PBC in combination with ursodeoxycholic acid in adults who do not respond adequately to ursodeoxycholic acid alone. The decision in Europe follows an accelerated approval granted by the FDA in June this year.

RALEIGH, N.C., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals is pleased to announce that KYZATREX® (testosterone undecanoate) CIII capsules will be highlighted in three research abstracts at the upcoming Sexual Medicine Society of North America (SMSNA) Annual Fall Scientific Meeting taking place from October 17th to 20th in Scottsdale, Arizona. KYZATREX is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The abstracts being presented include: "Combined Clomiphene and High-Dose Oral Testosterone Therapy in Hypogonadal Men: A Case Series" – This study, conducted by Dr. Andrew Sun, Grace Yoon BS, and Jimmy Vo BS, explores the effects of combining clomiphene with high-dose oral testosterone therapy, highlighting a novel approach to optimizing treatment outcomes for hypogonadal men. Dr. Sun will present this abstract."Initiating High-Dose Oral Testosterone Undecanoate Therapy in Hypogonadal Men" – This research, conducted by Dr. Andrew Sun, Jimmy Vo BS, and Grace Yoon BS, focuses on the initiation process for high-dose oral testosterone undecanoate therapy, offering valuable data for clinicians considering this treatment option for men with testosterone deficiency. Dr. Sun will present this abstract."Effects of Oral Testosterone Undecanoate on Semen Parameters in Hypogonadal Men: An Interim Analysis of a Prospective Pilot Study" – Presented by Gal Saffati, this study examines the impact of oral testosterone undecanoate on semen parameters, providing new insights into its effects on fertility in hypogonadal men. “We are proud to see KYZATREX featured in these important studies at the SMSNA Annual Meeting, contributing to a deeper understanding of testosterone therapy and its potential benefits for men with hypogonadism,” said Amit Shah, COO of Marius Pharmaceuticals. “These findings highlight the value of exploring new avenues in oral testosterone treatment.” The SMSNA Annual Fall Scientific Meeting gathers leading experts in sexual medicine, providing a platform for sharing innovative research and best practices. Marius Pharmaceuticals remains committed to advancing the science of testosterone therapy and improving outcomes for patients with testosterone deficiency. About KYZATREX® (testosterone undecanoate)KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established. Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX or visit www.kyzatrex.com. About Marius PharmaceuticalsMarius Pharmaceuticals strives to better the lives of men and women by focusing on therapies designed for hypogonadism or Testosterone Deficiency. Their vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com. Important Safety Information for KYZATREX® (testosterone undecanoate)UseKYZATREX (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.Important Safety Information for KYZATREX® (testosterone undecanoate) KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.If your blood pressure cannot be controlled, KYZATREX may need to be stopped.Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX. Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age). Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea). Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines. KYZATREX may cause other serious side effects including: Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.Increased risk of prostate cancer.Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.In large doses, KYZATREX may lower your sperm count.Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).Swelling of your ankles, feet, or body (edema), with or without heart failure.Enlarged or painful breasts.Breathing problems while you sleep (sleep apnea). Call your healthcare provider right away if you have any of the serious side effects listed above.The most common side effect of KYZATREX is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels. These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040. Keep KYZATREX and all medicines out of the reach of children.See Full Prescribing Information and Medication Guide for KYZATREX. Media Contact: Lilly Washburnlilly@mariuspharma.com