Breaking News
October 19, 2018 - Gene sequencing reveals crucial molecular aspects of Trypanosoma brucei
October 19, 2018 - New DNA vaccine strategy protects mice against lethal challenge by multiple H3N2 viruses
October 19, 2018 - Study shows close link between cytokine interleukin-1ß and obesity-promoted colon cancer
October 19, 2018 - Muscle mass plays a critical role in health, shows research
October 19, 2018 - Study finds undiagnosed prediabetes in many infertile men
October 19, 2018 - The Current issue of “The view from here” is concerned with Nanotherapeutic strategies
October 19, 2018 - Delay in replacing the Pap smear with HPV screening is costing lives
October 19, 2018 - Physicians battle pediatric diseases of ear, nose, throat in Zimbabwe | News Center
October 19, 2018 - Researchers investigate why some cancers affect only young women
October 19, 2018 - Drugmakers funnel millions to lawmakers; a few dozen get $100,000-plus
October 19, 2018 - Unselfish people tend to have more children and receive higher salaries
October 19, 2018 - New findings reveal potential cellular players in tumor microenvironment
October 19, 2018 - Human brain cell transplant offers insights into neurological conditions
October 19, 2018 - Parental education associated with increased family health care spending
October 19, 2018 - New statistical method estimates long- and short-term risk of recurrence of breast cancer in US women
October 19, 2018 - Father’s exposure to nicotine may cause cognitive deficits in descendants
October 19, 2018 - Could we prevent Alzheimer’s disease by treating herpes?
October 19, 2018 - Nurse-led care can be more successful in managing gout
October 19, 2018 - Trump administration, pharma exchange verbal volleys on drug-price transparency
October 19, 2018 - Duke researchers find way to detect blood doping in athletes
October 19, 2018 - Many primary care doctors are still prescribing sedative drugs for older adults
October 19, 2018 - Finger length can predict sexuality in women say researchers
October 19, 2018 - Study finds differences in side-effects experienced by male and female OG cancer patients
October 19, 2018 - Few Seniors Who Self-Harm Referred for Mental Health Care
October 19, 2018 - Don’t sweat the sweet stuff
October 19, 2018 - URMC researchers discover new approach to deliver therapeutics to the brain
October 19, 2018 - Middlemen suppliers can increase drug prices and hospital bills, say Johns Hopkins researchers
October 19, 2018 - Bliss funds research to find whether parental touch can help alleviate pain in premature infants
October 19, 2018 - Human neurons employ highly compartmentalized signaling, study shows
October 19, 2018 - Ultromics expands multiple clinical trials for coronary heart disease to the U.S.
October 19, 2018 - $11 million NIH grant for Clemson University helps launch new center for musculoskeletal research
October 19, 2018 - A new approach identified to control Zika virus, dengue fever
October 19, 2018 - Head Blows Without Concussion May Not Damage Brain, Study Claims
October 19, 2018 - US opioid use not declined, despite focus on abuse and awareness of risk
October 19, 2018 - Next-generation RNA sequencing technology sheds new light on human mitochondrial diseases
October 19, 2018 - UT Southwestern biochemist receives 2019 Breakthrough Prize in Life Sciences for innate immunity discovery
October 19, 2018 - The immune system also plays a key role in day-to-day function of healthy organs
October 19, 2018 - New tool may reveal how the brain structure impacts brain activity, human behavior
October 19, 2018 - Trump Administration announces ‘Winning on Reducing Food Waste’ initiative
October 19, 2018 - For-profit nursing home residents more likely to experience health issues caused by substandard care
October 19, 2018 - Incidence of stroke has risen steadily among marijuana users, show studies
October 19, 2018 - Conceptual framework proposed to examine role of exercise in multiple sclerosis
October 19, 2018 - Near infrared spectroscopy technique for accurate evaluation of chondral injuries
October 19, 2018 - Scientists receive $5.1 million grant to develop stem cell-based therapy for blinding retinal conditions
October 19, 2018 - Shorter physician encounters associated with antibiotic prescribing
October 19, 2018 - In the Spotlight: Enjoying research and exploring opportunities
October 19, 2018 - Physical activity lowers cardiovascular mortality risk in frail older adults
October 19, 2018 - New imaging tool helps visualize how sound-induced vibrations travel through the ear
October 19, 2018 - Key insights into the application, production of bioactive materials
October 19, 2018 - New urea sorbent could speed up the development of wearable artificial kidney
October 19, 2018 - Intensive care patients’ muscles less able to use fats for energy
October 19, 2018 - FDA Advisory Committee Recommends Approval of Dsuvia for the Treatment of Moderate-to-Severe Acute Pain
October 19, 2018 - 48,XXXY syndrome – Genetics Home Reference
October 19, 2018 - Physical exercise improves the elimination of toxic proteins from muscles
October 19, 2018 - How a new system improved wait times for Stanford kidney transplant patients
October 19, 2018 - Nutrition has bigger positive impact on bone mass and strength than exercise
October 19, 2018 - Study finds lack of progress in media representation of nurses over last 20 years
October 19, 2018 - Many people have trouble understanding differences between OCD and OCPD
October 19, 2018 - New family planning app found to be as effective as modern methods
October 19, 2018 - Gastric Banding, Metformin Similar for Improving Glycemia
October 19, 2018 - Physiologist publishes findings on the role of the protein titin in muscle contraction
October 19, 2018 - What digital health companies need to do to succeed
October 19, 2018 - N. Carolina Sees Alarming Spike in Heart Infections Among Opioid Users
October 19, 2018 - Video monitoring of TB therapy works well in urban and rural areas
October 19, 2018 - Determining acid-neutralizing capacity for OTC antacids
October 19, 2018 - Males who spend more time taking care of kids have greater reproductive success
October 18, 2018 - Study to explore bioethics of brain organoids
October 18, 2018 - Environmental conditions may drive development of multiple sclerosis
October 18, 2018 - Genetically modifying zebrafish provides more accurate disease models
October 18, 2018 - Purdue Pharma, Eisai announce positive topline results from Phase 3 study of lemborexant
October 18, 2018 - 5 Strength-Training Mistakes to Avoid
October 18, 2018 - Immune system’s balancing act keeps bowel disease in check
October 18, 2018 - Anti-inflammatory drug effective for treating lymphedema symptoms | News Center
October 18, 2018 - Keeping Your Voice Young
October 18, 2018 - One-time universal screening recommended to tackle increase in hepatitis C
October 18, 2018 - Researchers to develop new stem cell-based strategies for treating vision disorders
October 18, 2018 - Detecting epigenetic signature may help people stay ahead of inflammatory bowel disease
October 18, 2018 - Understanding AFib: Slowing down the dancing heart
October 18, 2018 - Using NMR to Reduce Fraud
October 18, 2018 - New automated model identifies dense breast tissue in mammograms
Lipocine Announces Outcome of FDA Advisory Committee Meeting for Tlando, Testosterone Replacement Therapy in Adult Males with Hypogonadism

Lipocine Announces Outcome of FDA Advisory Committee Meeting for Tlando, Testosterone Replacement Therapy in Adult Males with Hypogonadism

image_pdfDownload PDFimage_print

Treatment for Hypogonadism — Male

Lipocine Announces Outcome of FDA Advisory Committee Meeting for Tlando, Testosterone Replacement Therapy in Adult Males with Hypogonadism

SALT LAKE CITY, Utah, Jan. 10, 2018 /PRNewswire/ — Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced that the Bone, Reproductive and Urologic Drugs Advisory Committee (“BRUDAC”) of the U.S. Food and Drug Administration (“FDA”) voted six in favor and thirteen against the benefit/risk profile of Tlando, the Company’s oral testosterone product candidate for testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The role of BRUDAC is to provide recommendations to the FDA. The FDA decision on whether or not to approve the Tlando New Drug Application (“NDA”) is anticipated by the assigned Prescription Drug User Fee Act (“PDUFA”) goal date of May 8, 2018.

“We continue to believe that efficacy and safety results from numerous clinical studies with Tlando are consistent with other FDA approved TRT products,” said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. “We look forward to continuing to work with the FDA through the remainder of the review process.”

The BRUDAC discussions were based on the NDA currently under review by the FDA. The NDA includes efficacy and safety data on Tlando including the results from three Phase 3 clinical trials: the Dosing Validation (“DV”) clinical study, the Dosing Flexibility (“DF”) clinical study and the Study of Oral Androgen Replacement (“SOAR”) clinical study. Lipocine resubmitted the NDA to the FDA in August 2017 based on the results of the DV study. The DV study confirmed the efficacy of Tlando with a fixed dose regimen without the need for dose adjustment. Tlando successfully met the FDA primary efficacy guidelines in the DV study safety statistical analysis set (“SS”) where 80% of the subjects achieved average testosterone levels (“Cavg”) within the normal range with a lower bound confidence interval (“CI”) of 72%. Tlando was well tolerated upon 52-week exposure with no reports of drug related Serious Adverse Events (“SAEs”).

Although the FDA will consider the recommendation of BRUDAC, the final decision regarding the approval of TLANDO is made by the FDA solely, and the recommendations by BRUDAC are non-binding.

About Lipocine

Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies. Lipocine’s clinical development pipeline includes three development programs TLANDO, LPCN 1111 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. TLANDO was well tolerated and met the primary efficacy end-points in Phase 3 testing with twice daily dosing and is currently under FDA review. LPCN 1111, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in Phase 2 testing. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. 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 Lipocine’s product candidates and related clinical trials and the FDA review process relating to its product candidates, the expected timing of the FDA review process related to our resubmitted NDA, the impact of the BRUDAC recommendation on the FDA’s decision process, the path to approvability by the FDA of Lipocine’s development programs, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, the risk that BRUDAC may make a negative recommendation to the Commissioner of the FDA with respect to TLANDO, 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 that the FDA will determine there are deficiencies in our resubmitted NDA, the receipt of regulatory approvals, 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.

Posted: January 2018

Related Articles

  • Lipocine Announces FDA Acknowledgement of Tlando (LPCN 1021) NDA Resubmission – August 14, 2017
  • Lipocine Resubmits NDA for Its Oral Testosterone Product Candidate, LPCN 1021, for Treatment of Hypogonadism – August 9, 2017
  • Lipocine Receives Complete Response Letter (CRL) for LPCN 1021 From U.S. FDA – June 29, 2016
  • Lipocine Announces PDUFA Goal Date for LPCN 1021 NDA – November 12, 2015
  • FDA Accepts for Filing Lipocine’s NDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021 – October 29, 2015
  • Lipocine Submits NDA to FDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021 – August 31, 2015

Tlando (testosterone) FDA Approval History

Tagged with:

About author

Related Articles