New FDA Draft Guidance For Scored Tablets Positive for Accu-Break Pharmaceuticals, Inc.

PLANTATION, Fla.--(BUSINESS WIRE)--

Accu-Break Pharmaceuticals, Inc. (“ABP” or “the Company”), the inventor of patented scored tablet designs for easy and precise tablet splitting, believes their technologies comply with the Food and Drug Administration's (“FDA”) newly released guidance for testing and data requirements for scored tablets.

The draft guidance is music to ABP's ears as the Company had proposed the implementation of testing and standards for scored tablets to the U.S. Pharmacopeia (USP) in an article published in the Pharmacopeial Forum titled “Pharmacopeial Standards for the Subdivision Characteristics of Scored Tablets”. Not only was the article cited by the FDA in the guidance, but also a number of ABP's recommendations were included. ABP is currently licensing its Accu-Break™ technologies to companies that seek to meet FDA's proposed testing requirements.

“Our Accu-Break tablet technologies create scored dosage forms that patients may split easily and accurately,” said Dr. Elliot F. Hahn, Executive Chairman of ABP. “Ample data is available to show that when patients split their tablets, whether by hand or with a device such as a tablet splitter, the partial dose often deviates dramatically and can differ by more than 40% of the intended dose. We look forward to continuing to work with the FDA and the USP on the subject of making it safer for patients to split their tablets.”

The FDA drafted this guidance after recognizing that health insurance companies and physicians are increasingly recommending that patients split tablets, either to adjust the patient's dose or as a cost-saving measure, and that the U.S. lacked standards or regulatory requirements related specifically to the functionality of scored tablets. Confirming the need for an accurate dose when splitting a tablet, survey data generated by ABP shows that 88% of physicians agreed that it was important that an accurate partial dose be obtained when patients split their tablets.

About Accu-Break Pharmaceuticals, Inc.

Accu-Break Pharmaceuticals, Inc. (ABP) is a technology licensing and product development company. ABP has invented, developed and patented a suite of novel Accu-Break™ technologies that enable pharmaceutical tablets to be made that can be subdivided by hand into accurate partial doses with the intent of making it easier and safer for patients to adjust their dose. The Company is currently developing its first Accu-Break product, an Accu-Break-formatted anticoagulant, and is licensing the Accu-Break technologies for use in other products that are currently in development. ABP currently has 17 patents issued and 37 patents pending worldwide.

ABP Disclosure Notice: This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein or which are otherwise made by or on behalf of the Company that are not statements of historical facts may be deemed forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “to,” “plan,” “expect,” “believe,” “anticipate,” “intend,” “could,” “should,” “would,” “estimate,” or “continue,” or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements. Readers are cautioned that all forward-looking statements involve risk and uncertainties which may cause results to differ materially from those set forth in the statements. Such risks and uncertainties include, but are not limited to the following: the success of research and development activities and the speed with which regulatory authorizations and product launches may be achieved; government regulation generally; competitive developments; the ability to successfully market products domestically and internationally; difficulties or delays in manufacturing or issues relating to manufacturing capacity; commercial obstacles to the successful introduction of brand products generally; legal defense costs, insurance expenses, settlement costs, and the risk of an adverse decision or settlement relating to product liability, patent protection, governmental investigations, and other legal proceedings; the Company's ability to acquire and protect patents and other intellectual property both domestically and internationally; the absence of certainty regarding the receipt of required regulatory approval or the timing or terms of such approvals; any changes in business, political and economic conditions; business interruption due to hurricanes or other events outside of the Company's control. No Accu-Break tablets have been marketed.

Readers are cautioned not to place reliance on these forward-looking statements, which are valid only as of the date they were made. The Company undertakes no obligation to update or revise any forward-looking statements to reflect new information or the occurrence of unanticipated events or otherwise, except as expressly required by law.