Testosterone Undecanoate

SALT LAKE CITY , Dec. 17, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis. LPCN 1148, an oral prodrug of bioidentical testosterone, was recently studied in a proof-of-concept (POC) Phase 2 study in patients with decompensated cirrhosis. Treatment with LPCN 1148 in the POC study improved sarcopenia and associated clinical outcomes. LPCN 1148 is targeted to be a "First in Class" product candidate with a novel mechanism of action for management of cirrhosis. "We are excited the FDA has recognized that sarcopenia in patients with cirrhosis is a serious condition and that LPCN 1148 has the potential to provide clinical benefits for these patients where no therapy currently exists," said Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine. "We are encouraged that the positive primary endpoint results from our successful proof-of-concept study were recognized by the FDA as evidence of clinical effectiveness of LPCN 1148 in improving sarcopenia in patients with cirrhosis." The Fast Track program is designed to accelerate the development and expedite the review of products, such as LPCN 1148, which are intended to treat serious diseases and for which there is an unmet medical need. Fast Track designation lends eligibility for some, or all, of the following: About Cirrhosis Cirrhosis is an end stage liver disease of varying etiologies such as alcoholic liver disease, chronic viral hepatitis, nonalcoholic fatty liver disease and primary cholangitis. Complications of cirrhosis include decompensation events such as hepatic encephalopathy due to systemic ammonia buildup, variceal bleeding, and ascites, which require frequent hospitalizations. In addition, many patients exhibit sarcopenia (low muscle mass). Over 382,000 patients have been diagnosed with decompensated liver cirrhosis in the US, with few options for managing their disease other than liver transplant. Poor quality of life is common while waiting for a liver transplant. Although there is a limited supply of donor livers, transplant is the only cure for end-stage cirrhosis. About Sarcopenia Sarcopenia, a progressive loss of muscle mass and function, is a common and debilitating complication in patients with decompensated cirrhosis. It significantly impacts quality of life and worsens clinical outcomes, including reduced survival rates. Patients with decompensated cirrhosis and sarcopenia exhibit significantly shorter overall survival than those without sarcopenia. Currently, the only curative therapy for decompensated cirrhosis is liver transplant. There are no FDA approved drugs to treat sarcopenia in decompensated cirrhosis beyond treatment of the underlying conditions. About LPCN 1148 LPCN 1148 comprises testosterone dodecanoate, a unique androgen receptor agonist. It is targeted as a differentiated intervention option with a novel multimodal MOA to elicit potential benefits in management of cirrhosis and associated comorbidities of cirrhosis. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs. Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in obesity management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of non-cirrhotic NASH. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit www.lipocine.com. Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding development and commercialization of TLANDO and TLANDO XR (LPCN 1111) by our licensees, the amount of the license fee, milestone payments, and royalty payments we will ultimately receive, the ability of our licensees to grow the TLANDO franchise, our product development efforts, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1148 and LPCN 2401, the timing of our submission of a NDA with the FDA for LPCN 1154, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates to treat CNS disorders, we may not have sufficient capital to complete the development processes for our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

The Deal Gives Gameday Men’s Health Patients Access to The FDA-Approved Oral Testosterone Therapy At 250+ Health Centers RALEIGH, N.C., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Gameday Men’s Health, the leader in men’s health clinics nationwide, today announced it is expanding its testosterone therapy options to include KYZATREX® (testosterone undecanoate) CIII capsules. Partnering with Marius Pharmaceuticals, Gameday Men’s Health now provides access to FDA-approved KYZATREX, a prescription medication for adult men who have low or no testosterone due to certain medical conditions, in all Gameday Men’s Health centers across 48 states. KYZATREX is available in an oral form, providing a non-invasive and convenient alternative to traditional injection-based methods. Gameday Men’s Health is a pioneering health clinic designed to help men reclaim their lives by optimizing four common areas of male concern - low testosterone, erectile dysfunction and enhancement, weight loss, and vitamin therapy. With in-house labs, expert medical teams, and personalized treatment plans, Gameday delivers discreet, effective solutions to support men’s optimal health and vitality. Shalin Shah, CEO of Marius Pharmaceuticals, says, “Given the staggering numbers of testosterone deficient men across the country, we are glad to see KYZATREX offered at one of the most rapidly growing men’s clinics. It is critical that we normalize this critical, metabolic therapy so men feel comfortable getting the care that they need and glad to see Gameday solving this issue.” The launch of KYZATREX at Gameday Men’s Health comes at a time when testosterone deficiency is a rising global epidemic as it affects approximately four in 10 men older than 45 years and 30-50% of men with obesity or type 2 diabetes, according to the Endocrine Society (2022). Testosterone deficiency is bi-directional with metabolic diseases and early research indicates a role in further conditions such as depression and inflammatory diseases. While TRT has traditionally consisted of injections, implanted pellets, patches, or gels, KYZATREX instead delivers testosterone through a twice-daily, softgel capsule that is safe and convenient. The oral delivery excludes the administration pain, mess, transference risk to others around you, and changes to eating habits which can occur with other TRT delivery systems. KYZATREX is primarily absorbed via the lymphatic system, effectively bypassing the liver and avoiding toxicity. “Our goal has always been to make men's health accessible and adaptable. Oral TRT provides men with a choice in TRT that aligns with their preferences, allowing them to feel their best with minimal interruption to their daily lives,” said Evan Miller, CEO and Founder of Gameday Men’s Health. For more information about Gameday Men’s Health visit gamedaymenshealth.com. For more information about KYZATREX, visit www.kyzatrex.com, and for more information about Marius Pharmaceuticals, visit www.mariuspharma.com. About Marius Pharmaceuticals Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company's 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. About Gameday Men’s HealthGameday Men's Health is a premier men’s health clinic offering a range of services, including testosterone replacement therapy, erectile dysfunction treatment, weight loss programs, and vitamin therapy. Founded in 2018, this franchise is designed to help men transform their lives with a simple, three-step signature process: testing, proprietary wellness plans, and personalized treatment sessions. For more information, please visit www.gamedaymenshealth.com 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) and 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 symptoms of low testosterone, including quality of life, energy/fatigue, erectile function, sexual intercourse, and 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 for KYZATREX below, including Boxed Warning for potential increased blood pressure, or visit www.kyzatrex.com.Important Safety Information for KYZATREX® (Testosterone Undecanoate Capsules)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® 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 visiting www.mariuspharma.com]. Keep KYZATREX and all medicines out of the reach of children. See Full Prescribing Information and Medication Guide for KYZATREX. Media Contact:Marius PharmaceuticalsLilly Washburn lilly@mariuspharma.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3da5b291-b193-4057-9ec7-7e72839cddd9