Breaking News
March 21, 2018 - Hydrogel may accelerate healing of diabetic ulcers
March 21, 2018 - Dermira’s Two Phase 3 Trials Evaluating Olumacostat Glasaretil in Patients with Acne Vulgaris Did Not Meet Co-Primary Endpoints
March 21, 2018 - ‘Oh, It Was Nothing’
March 21, 2018 - Herbal drug kratom linked to salmonella illnesses, CDC says
March 21, 2018 - New optical point-of-care device could enhance screening for thyroid nodules
March 21, 2018 - FDA Expands Approval of Adcetris (brentuximab vedotin) for First-Line Treatment of Stage III or IV Classical Hodgkin Lymphoma in Combination with Chemotherapy
March 21, 2018 - Eosinophilic Esophagitis: Late Manifestation of Allergic March
March 21, 2018 - Signaling pathway involving the Golgi apparatus identified in cells with Huntington’s disease
March 21, 2018 - Quintupling inhaled steroid doses may not benefit children with asthma
March 21, 2018 - Study shows clear connection between cardiovascular fitness in middle age and dementia risk
March 21, 2018 - Premature babies have higher risks of health complications in Bangladesh
March 21, 2018 - Child’s temperament and parenting influence weight gain in babies
March 21, 2018 - Researchers find the heart to be capable of arrhythmia termination after local gene therapy
March 21, 2018 - Inhealthcare to provide digital infrastructure for NHS to help protect people from falls
March 21, 2018 - Flu Season Finally Slowing Down
March 21, 2018 - Mixed Results for Shorter DAPT in ACS Patients
March 21, 2018 - Scientists discover fish scale-derived collagen effective for healing wounds
March 21, 2018 - Genomics England announces new partnership to improve efficiency of next-generation sequencing analysis
March 21, 2018 - Adjuvant AC chemotherapy found to be effective in treating HRD-positive breast cancer patients
March 21, 2018 - Researchers identify new treatment targets for lung diseases using big data
March 21, 2018 - Kids see more women in science than five decades ago
March 21, 2018 - Research shows link between chronic fatigue syndrome and lower thyroid hormone levels
March 21, 2018 - Alzheimer’s disease on the rise
March 21, 2018 - Two Agents Equal as Pretreatment for Adrenal Tumor Surgery
March 21, 2018 - ‘Icebreaker’ protein opens genome for T cell development, researchers find
March 21, 2018 - Women in medicine shout #Metoo about sexual harassment at work
March 21, 2018 - Mother’s pre-pregnancy waist size may be linked to child’s autism risk
March 21, 2018 - Second hand marijuana smoke can cause serious damage
March 21, 2018 - International study shows benefits of using MRI at the start of prostate cancer diagnosis
March 20, 2018 - Santhera Reports Outcome of Exploratory Trial with Idebenone in PPMS Conducted at the NIH
March 20, 2018 - ECG Patch Ups At-Home Afib Diagnosis in mSToPS Trial
March 20, 2018 - ROS-scavenging nanozymes for anti-inflammation therapeutics
March 20, 2018 - Genomics England announces appointment of global genomics pioneer as first CEO
March 20, 2018 - Test flight at German Aerospace Center in Cologne demonstrates functionality of deficopter
March 20, 2018 - Music therapy helps treat combat-related psychological injuries in military personnel
March 20, 2018 - Innovative psychotherapeutic treatment protocol for obsessive-compulsive disorders
March 20, 2018 - Weight loss after lap-band surgery alleviates arthritic knee pain
March 20, 2018 - New diabetes drug may help obese people shed body weight
March 20, 2018 - Novel Peanut OIT a Winner in Phase III Trial
March 20, 2018 - Can gene therapy be harnessed to fight the AIDS virus?
March 20, 2018 - Education and academic achievement can lessen effects of child abuse, neglect
March 20, 2018 - Researchers develop new algorithm to make CPR more effective
March 20, 2018 - Diabetes medication reduces chance of late miscarriage, premature birth among women with PCOS
March 20, 2018 - SSRIs may be more effective option for treating anxious youth, UC research shows
March 20, 2018 - Antibiotics could benefit women suffering from chronic bladder pain
March 20, 2018 - Health Highlights: March 16, 2018
March 20, 2018 - Interventional Radiology Has a Problem of ‘Unseen’ Value
March 20, 2018 - Antibodies show effectiveness for HIV prevention and promise for treatment and cure
March 20, 2018 - New 3-D-printed technology will improve radiology training
March 20, 2018 - New study identifies key role for particular gene in 16p11.2 deletion syndrome
March 20, 2018 - Red and processed meat increase the risk of liver disease
March 20, 2018 - 50% of Australians do not brush teeth twice a day
March 20, 2018 - American Gene Technologies receives second immuno-oncology patent
March 20, 2018 - Study finds no link between long-term violent video game play and adult aggression
March 20, 2018 - Weight loss surgery widely underutilized among young patients with severe obesity
March 20, 2018 - Scientists uncover new answers to cell aging in children with rare, fatal disease
March 20, 2018 - The Pistoia Alliance Calls for Greater Life Sciences Collaboration to Build the ‘Lab of the Future’
March 20, 2018 - Morning Break: Psychopathic Thought; Americans Flout Zzz’s; Farm to Pharma
March 20, 2018 - Perceptions of old age change as we age
March 20, 2018 - New standards for public involvement in research launched across the UK
March 20, 2018 - Whole Genome Sequencing used as diagnostic solution for TB
March 20, 2018 - Researchers show how two cancer genes work together to trigger leukemia
March 20, 2018 - Scientists discover basic molecular mechanism that helps understand how ALS works
March 20, 2018 - Multi-center study to evaluate promising new intervention for upper limb dysfunction after SCI
March 20, 2018 - Researchers develop technology to program DNA for delivering cancer drugs
March 20, 2018 - Northwestern scientists bring precision medicine to rheumatoid arthritis
March 20, 2018 - Research suggests possible link between heading a soccer ball and brain imbalance
March 20, 2018 - Robocall increases diabetic retinopathy screening rates among poor minorities
March 20, 2018 - INSYS Therapeutics Initiates Phase 3 Clinical Trial of Cannabidiol (CBD) Oral Solution for Treatment of Infantile Spasms
March 20, 2018 - Little Talk Between Docs and Patients Pre-PSA Screen
March 20, 2018 - Women GPs bring remote care to rural Pakistan
March 20, 2018 - Adults skipping vaccines may miss out on effective new shingles shot
March 20, 2018 - Suppressing emotions appears to reduce negative memories
March 20, 2018 - Epidural stimulation can safely, effectively normalize blood pressure in patients with SCI
March 20, 2018 - ‘Fast track’ project shows promising results in cancer whole genome analyses
March 20, 2018 - Advanced insulin pump system can also manage type 1 diabetes in children, study shows
March 20, 2018 - Flu risk less on flights if in a window seat finds study
March 20, 2018 - Sarepta Therapeutics Announces Plan to Submit a New Drug Application (NDA) for Accelerated Approval of Golodirsen (SRP-4053) in Patients with Duchenne Muscular Dystrophy (DMD) Amenable to Skipping Exon 53
March 20, 2018 - Post-Transplant Fatty Liver Disease on the Rise
March 20, 2018 - New mutation linked to ovarian cancer can be passed down through dad
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

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 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