Dosing with Tamsulosin DRS fasted and Tamsulosin DRS fed were successfully shown to be bioequivalent with FLOMAX Fed based on AUC. The AUC equivalence is the key determinant of drug exposure over time. The Tamsulosin DRS formulation did not meet the remaining bioequivalence criterion for the peak value (Cmax). The BE clinical trial was a 21-day single dose comparison of Tamsulosin DRS slow release granule formulation versus FLOMAX® capsules in 36 patients who have either fasted or eaten prior to dosing. 34 subjects completed the study.
“Having met bioequivalence for AUC, we have the ability to adjust the blend of particle sizes in the proprietary granule formulation to address the Cmax difference, because Cmax is dependent upon particle size,” said Lynn Gold PhD, Vice President of Scientific and Regulatory Affairs, Camargo Pharmaceutical Services.
The current formulation registration batch that is undergoing stability testing is still acceptable for NDA submission. The time required to test stability remains our time limiting step. The new BE study to validate the revised formulation should be accomplished by the first quarter of calendar 2018 which is within the current stability time window that will allow us to remain on track with our planned NDA submission.
“Today’s announcement supports the clinical advancement of Tamsulosin DRS. The expected timing of the additional formulation adjustment should allow us to remain on track for a pre-NDA meeting in early 2018 and an NDA submission in the first half of calendar 2018,” said
Supported by the Stage 1 and Stage 2 BE clinical trial results, the company also plans to request a meeting with the
“Because Veru has a novel slow release granule formulation of Tamsulosin that does not have a food requirement, we will also begin development of an oral capsule containing these granules. The planned NDA filing would be for both drug products - the granule formulation and the capsules,” said
About Tamsulosin DRS (Tamsulosin HCl extended release for oral suspension)
Tamsulosin DRS is a new granule formulation containing the active pharmaceutical ingredient in FLOMAX® (tamsulosin HCI) capsules. FLOMAX® is indicated for the treatment of BPH, also known as enlargement of the prostate. Tamsulosin is a selective alpha1 adrenoreceptor antagonist specific to receptors located in prostate and bladder smooth muscle. Symptoms associated with BPH occur because of a change in the functioning of the prostate and bladder smooth muscle that can lead to constricted urinary flow, urinary retention, urinary infection, kidney damage and a life-threatening blood infection called urosepsis. Blocking alpha1 adrenoreceptors relaxes smooth muscle resulting in improved urinary flow and reduction of BPH symptoms.
To help support these clinical development programs, the company markets and sells the FC2 Female Condom® (now available by prescription in the US including through the virtual doctor smartphone app “HeyDoctor” at www.fc2.us.com) and through The Female Health Company Division in the Global Public Health Sector. The Female Health Company Division markets to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world. In addition, the company markets and sells the PREBOOST® medicated individual wipe which is a male genital desensitizing drug product for the prevention of premature ejaculation that is being co-promoted with
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is the most experienced team of experts providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory, and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure Agency buy-in every step of the way. With alignment through pre-Investigational New Drug (pre-IND) meeting planning and preparations, Camargo maintains and ensures consistency throughout the drug development program, which increases the likelihood of NDA and future market success. Routinely holding three to six pre-IND meetings a month, Camargo works with product developers across more than 25 countries. For more about Camargo Pharmaceutical Services, visit http://camargopharma.com
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Press Release Kari Sharp