Wired News – Egalet Shares Positive Top-Line Results from Phase-3 Study of Egalet-002 in Patients with Chronic Low Back Pain

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LONDON, UK / ACCESSWIRE / November 30, 2017 / Active-Investors issued a free report on Egalet Corp. (NASDAQ: EGLT), which is readily accessible upon registration at www.active-investors.com/registration-sg/?symbol=EGLT as the Company’s latest news hit the wire. On November 28, 2017, the fully-integrated specialty pharmaceutical Company, focused on developing, manufacturing, and commercializing innovative treatments for pain and other conditions, reported positive top-line results from the second of the two Phase-3 studies for Egalet-002 in patients with moderate-to-severe chronic low back pain. Sign up now for our free research reports at:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Egalet most recent news is on our radar and we have decided to include it on our blog post. Today’s free coverage is available at:

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About Egalet-002

Egalet-002 is an abuse deterrent, extended-release oxycodone developed using a unique application of Egalet’s proprietary Guardian Technology.

About the Phase-3 Study

The Phase-3 Study of Egalet was conducted in two parts.

The first one evaluated the safety and tolerability of Egalet-002 for up to 56 weeks in opioid-experienced patients with moderate-to-severe chronic non-cancer pain. In that study, Egalet was administered to around 150 patients for six months and at least 50 patients for one year.

The second of the two Phase-3 studies was a multicenter, double-blind, enriched enrollment, randomized withdrawal study, meant to evaluate the safety and efficacy of Egalet-002 compared to placebo in opioid-experienced and opioid-naive patients with moderate-to-severe chronic low back pain.

Positive Top-Line Results

The results for the first Phase-3 safety study were declared on November 16, 2017. It showed that Egalet-002 was mostly well tolerated and the incidence of adverse events reported were in-line with outcomes expected following treatment with an extended-release oxycodone formulation.
The results for the second Phase-3 study were declared on November 28, 2017. The study accomplished its primary endpoints – a statistically significant difference was noted in the average pain intensity from baseline (at randomization) to week 16 between the Egalet-002 and placebo treatment groups (p<0.0001).

Optimistic Remarks from Egalet’s CEO

Bob Radie, President and Chief Executive Officer (CEO) at Egalet, stated that the second Phase-3 study results validated that Egalet-002 has the potential to provide effective pain relief for patients with moderate-to-severe chronic back pain.

Chronic back pain, coupled with prescription abuse epidemic, has become increasingly prevalent in the society. Thus, the development of more abuse-deterrent products like Egalet-002 is important for the communities.

Overview about Egalet’s Guardian Technology

The Guardian Technology is a polymer matrix tablet technology, which utilizes an innovative application of the well-characterized manufacturing process of injection molding, which results in tablets that are hard and difficult to manipulate for misuse and abuse.
It has many applications, especially in developing abuse-deterrent forms of commonly abused prescription medications.
This approach has the potential to design tablets with controlled-release profiles, as well as physical and chemical properties that have proved to resist both common and rigorous methods of manipulation.
In fact, tablets that have been manufactured with the Guardian Technology have exhibited improved resistance to physical methods of manipulation, such as cutting, crushing, grinding, or breaking, using a variety of mechanical and electrical tools. However, the tablets have proved to be resistant to chemical manipulation and have made attempts at extraction and turn into a viscous hydrogel on contact with liquid, which make syringe-ability very difficult.

Stock Performance Snapshot

November 29, 2017 – At Wednesday’s closing bell, Egalet’s stock fell 4.20%, ending the trading session at $1.25.

Volume traded for the day: 2.60 million shares, which was above the 3-month average volume of 1.05 million shares.

Stock performance in the last month – up 25.53%; previous three-month period – up 7.26%

After yesterday’s close, Egalet’s market cap was at $48.32 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.3% at the end of the session.

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