TAMSULOSIN XR capsules and sprinkles for the treatment of BPH

TAMSULOSIN XR capsules and sprinkles

Scientific Overview

TAMSULOSIN XR capsules and sprinkles are new proprietary slow release granule formulations containing the active pharmaceutical ingredient in FLOMAX® (tamsulosin HCL) capsules which is a commonly used medicine for the treatment of BPH, also known as enlargement of the prostate. FLOMAX® is indicated for the treatment of the signs and symptoms of BPH. Tamsulosin is a selective alpha1 adrenergic receptor blocking drug that is specific for the alpha1 adrenergic receptors located in the smooth muscle of the prostate and bladder neck. Symptoms associated with BPH typically occur as a result of increased smooth muscle tone of the prostate and bladder which leads to constriction of urinary flow, urinary retention, urinary infection, kidney damage and life threatening blood infection called urosepsis. Blocking these alpha1 adrenergic receptors relaxes the smooth muscles of the prostate and bladder neck resulting in the improvement of urinary flow rate and reduction in the symptoms of BPH.

FLOMAX® capsules are required to be taken with food since taking the drug on an empty stomach also results in high drug levels that also results in higher risks for the postural hypotension (sudden drop in blood pressure upon standing that can lead to fainting). The FDA approved dosing instructions for Flomax also state that the capsules should not be crushed, chewed or opened because men will have drug levels that are too high and are placed at higher risk for postural hypotension. Tablets and capsules are problematic for 15% of men over the age of 60 who have difficulty swallowing tablets and capsules and the up to 60% of men in long term facilities who have difficulty swallowing tablets and capsules because of certain medical conditions, including degenerative neurological diseases like Parkinson’s or having suffered a stroke. Not being able to take alpha blocker drugs for BPH, like FLOMAX®, because of difficulty swallowing tablets and capsules may lead to the increased risk of acute urinary retention, urinary catheterization, urosepsis and death. Because TAMSULOSIN XR capsules and sprinkles are new proprietary granule formulations containing the active pharmaceutical ingredient in FLOMAX®, it would provide a more convenient and reliable way to deliver therapeutic levels of tamsulosin to men who have difficulty swallowing tablets and capsules.

TAMSULOSIN XR capsules and sprinkles

Development Plan

This new formulation called TAMSULOSIN XR capsules and sprinkles contains the same tamsulosin active pharmaceutical ingredient that is found in FLOMAX® (tamsulosin HCL) capsules and, as such, if comparable blood levels are demonstrated between TAMSULOSIN XR and Flomax, would be expected to have the same efficacy and safety as FLOMAX®. FDA has agreed that the Flomax can be referenced under a 505(b)(2) NDA submission for TAMSULOSIN XR capsules and sprinkles. Veru has completed a Pre-IND meeting with FDA, completed an initial comparative bioavailability study and continues to refine the formulation.

TAMSULOSIN XR capsules and sprinkles

Market

The initial marketing plan will target the community-based urologist and those BPH patients that have difficulty swallowing tablets or capsules and what the convenience of not having any “food effect” common among other highly selective alpha blockers. The U.S. market for all alpha blockers for BPH is estimated in 2018 to be $633M annually per IMS. Men in long term care or nursing homes have up to a 60% prevalence of swallowing difficulties and account for about 13% of total tamsulosin sales, whereas over 15% of men over 60 years of age in the general population have difficulty swallowing tablets and capsules.