Acetaflex Case Study

Aug 20, 2019

Enabling Long Term Pain Relief With Innovative New Technology

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The Challenge
Acetaminophen, one of the most commonly used pain relievers on the market, is used
to treat mild to moderate pain—including headaches, muscle aches, arthritis, backache,
toothaches—as well as to reduce fever.

Consistent dosing is key when taking acetaminophen, as the drug is not without its
drawbacks and risks: taking more than recommended does not provide any additional
relief and can lead to liver damage.

Therefore, there was a clear need for extended release acetaminophen providing simple
titration and twice-daily dosing. However, conventional extended release tablets ‘dosedump’
when broken, exposing patients to harmful levels of drug. A tablet that could be
easily broken without exposing patients to inconsistent, even harmful levels of drugs,
would need to be developed.

The Solution
ACETAFLEX ER™, a breakable extended release form of acetaminophen, was developed
using FLEXITAB™ technology. FLEXITAB tablets can be broken into pieces with no change in
performance, therefore providing all the convenience of extended release without the risk.

FLEXITAB tablets, like ACETAFLEX ER, are robust yet can be precisely broken with just
one hand, leading to easier to swallow doses. High dosage strength products may be
difficult to swallow for the young and the elderly, but breakable tablets address this
issue directly.

The Outcome
By simplifying titration for the patient and the physician, ACETAFLEX ER provides
multiple strengths from the same tablet. This results in fewer medication errors and
fewer tablets to deal with.

A 400-patient Phase II study have demonstrated that ACETAFLEX ER provides pain relief
in less than 30 minutes, analgesia maintained for up to 12hr versus placebo, a patient
efficacy rating of “good to excellent” of 70%, and excellent tolerability.
ACETAFLEX ER and other products using FLEXITAB technology are available now for
licensing.

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