Regabatin™

Regabatin™

Regabatin: A New Solution Filling a Controlled Release Gap

Our once-a-day Regabatin™ (pregabalin) extended-release capsules are indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury and fibromyalgia. Regabatin™ is based on our controlled release drug delivery technology platform which utilizes the symptomatology and chronobiology of fibromyalgia in a formulation intended to provide a higher exposure of pregabalin during the first 12 hours of dosing. Based on positive feedback and guidance from the FDA, we submitted an IND application for Regabatin™ in August 2015. The FDA completed its review of the IND application and provided constructive input that we will use towards further development of the program.

The brand reference drug is Lyrica® (immediate release pregabalin), and at the current time, there are no FDA approved controlled-release formulations on the market. A controlled-release version of pregabalin should reduce the number of doses patients take, potentially improving patient compliance and clinical outcomes.

Product Pipeline

Product Brand US Sales Indication Clinical/BE Studies FDA Filed FDA Approved
NDA
Regabatin™ Lyrica® $4.57B* Neuropathic Pain
Clinical/BE Studies Phase in progress
FDA Filed Phase not started
FDA Approved Phase not started

Source: Represents sales for all strengths, unless otherwise noted, for the 12 months ended August 2017 in the US., including sales of generics in TRx MBS Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer’s published catalog or list prices to wholesalers, and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price. Source: Symphony Health Solutions Corporation. The information attributed to Symphony Health Solutions Corporation herein is provided as is, and Symphony makes no representation and/or warranty of any kind, including but not limited to, the accuracy and/or completeness of such information.

Phase I Clinical Trial

We successfully completed an initial Phase I clinical trial of a controlled-release pregabalin formulation. This was the first bioavailability study of our controlled-release pregabalin versus Lyrica® (immediate release pregabalin).

Phase I Clinical Trial Results

We conducted and analyzed the results of six Phase I clinical trials involving a twice-a-day formulation and a once-a-day formulation. For formulations directed to certain indications which include fibromyalgia, the results suggested that Regabatin™ 82.5 mg BID dosage was comparable in bioavailability to Lyrica® 50 mg (immediate-release pregabalin) TID dosage. For formulations directed to certain other indications which include neuropathic pain associated with diabetic peripheral neuropathy, the results suggested that Regabatin™ 165 mg once-a-day dosage was comparable in bioavailability to Lyrica® 75 mg BID dosage.

Partnership Opportunities

With the help of our partners, we apply our proprietary delivery platform technologies and expertise in pharmaceutics, drug delivery and drug manufacture with the goal of minimizing the risk, time and manufacturing cost of bringing the finished product to market.

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