Endo Pharmaceuticals Inc., a subsidiary of Endo International plc – Ordinary Shares (NASDAQ:ENDP), announced new data to be presented supporting the safety and tolerability of BELBUCA™ (buprenorphine) buccal film for the long-term management of chronic pain in patients requiring around-the-clock opioids. The findings will be presented during a poster session at theInternational Conference on Opioids (ICOO 2016) in Boston, which takes place June 5-7.
BELBUCA™ is the first and only buprenorphine formulation developed with a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management. In the Phase 3, open-label study, many patients receiving treatment with BELBUCA™ twice daily reported a low incidence of typical opioid-like side effects such as nausea and vomiting during treatment titration and for up to 48 weeks of daily therapy. The study also found that BELBUCA™ was effective during long-term treatment and provided sustained pain relief throughout the treatment phase (48 weeks) as measured on the numeric rating scale (NRS).
“Many patients living with chronic pain require long-term treatment to control their suffering, so it is important that patients have options to manage their pain,” said Martin Hale, M.D., Medical Director, Gold Coast Research, Plantation FL, and one of the study’s investigators. “These new findings support the safety and tolerability of treatment with BELBUCA™ across a broad range of dosage strengths. The data may provide healthcare professionals with important information when making treatment decisions for patients living with chronic pain who require daily, around-the-clock opioid treatment and for whom alternative treatment options are inadequate.”
The Phase 3, open-label study enrolled 506 patients with moderate to severe chronic pain, requiring continuous around-the-clock opioid treatment who underwent a dose titration period of up to six weeks followed by a long-term treatment phase (48 weeks). Among these patients, 435 patients went on to receive long-term treatment (<48 weeks) with BELBUCA™ 300 µg (n=52), 450 µg (n=45), 600 µg (n=141), 750 µg (n=62) or 900 µg (n=135) administered every 12 hours. The primary endpoint was to determine the long-term safety and tolerability of BELBUCA™ (dosed every 12 hours); the secondary endpoint was to determine the long-term efficacy of BELBUCA™ (dosed every 12 hours).
In the safety analysis, adverse events (AEs) (> 3%) occurred in 43.1% and 54.0% of patients during the titration (n=506) and long-term treatment (n=435) phases, respectively. The most common AEs included nausea (10.3%), constipation (5.9%) and headache (3.6%) during the titration phase, and nausea (8.3%), vomiting (5.1%) and upper respiratory tract infection (4.8%) during long-term treatment.
For the efficacy endpoint, the average daily pain intensity score during the treatment phase was between 2.9 and 3.1 on a scale of 0 (no pain) to 10 (worst pain imaginable). In addition, the need for rescue medication to relieve breakthrough pain decreased from an average of 3 tablets in the titration to 1.1 tablets in the long-term treatment phase.
“BELBUCA™ is the first and only buprenorphine buccal film combining the established safety and proven efficacy profile of buprenorphine with a novel buccal film delivery system that adds convenience and flexibility of dosing options and presents a unique approach for chronic pain management,” said Susan Hall, Ph.D, Executive Vice President, Chief Scientific Officer and Global Head of Research & Development and Quality at Endo. “With these new study findings, Endo is continuing our focus on addressing an important patient need for safe and effective treatment options for long-term pain relief.” (Original Source)
Shares of Endo are up 1.5% to $17.75 in after-hours trading. ENDP has a 1-year high of $88.54 and a 1-year low of $12.56. The stock’s 50-day moving average is $21.36 and its 200-day moving average is $42.44.
On the ratings front, Endo has been the subject of a number of recent research reports. In a report issued on May 18, RBC analyst Randall Stanicky reiterated a Hold rating on ENDP, with a price target of $26, which represents a potential upside of 49.1% from where the stock is currently trading. Separately, on the same day, Stifel Nicolaus’ Annabel Samimy reiterated a Buy rating on the stock and has a price target of $25.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Randall Stanicky and Annabel Samimy have a total average return of 3.3% and 11.9% respectively. Stanicky has a success rate of 50.0% and is ranked #977 out of 3896 analysts, while Samimy has a success rate of 57.6% and is ranked #356.
Overall, one research analyst has rated the stock with a Sell rating, 7 research analysts have assigned a Hold rating and 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $23.00 which is 31.9% above where the stock closed yesterday.
Endo International Plc operates as a pharmaceutical company. It focuses on developing, manufacturing, and distributing of branded and generic pharmaceutical products. The company was founded on October 31, 2013 and is headquartered Dublin, Ireland.