Nektar Therapeutics’ (NKTR - Free Report) shares surged 42.6% after the company announced positive results from SUMMIT-07 phase III efficacy study evaluating its investigational opioid analgesic candidate, NKTR-181, in patients with moderate to severe chronic low back pain. The opioid-based drug was studied to relieve pain without causing potential abuse and addiction.
Nektar’s shares have significantly outperformed the Zacks classified Medical-Drugs industry so far this year. The company’s shares gained 80.4%, while the industry registered an increase of 3.7%.
The phase III SUMMIT-07 study was designed to compare twice-daily dosing of NKTR-181 versus placebo in over 600 patients with moderate to severe chronic low-back pain, who were new to opioid therapy. The study met the primary endpoint and demonstrated significantly improved chronic back pain relief on treatment with NKTR-181 compared with placebo. Key secondary endpoints were also of high statistical significance. Notably, the trial included an open-label titration period wherein patients were titrated to a tolerated, effective dose of NKTR-181 (100 mg to 400 mg twice-daily). During this period, patients experienced a decrease in average pain score by 65%. The study also showed that NKTR-181 helped in an overall improvement in the quality of life with less disturbance during sleep.
Full data from the SUMMIT-07 study will be presented at a medical meeting in the second half of 2017.
Please note that the FDA granted Fast Track designation for the NKTR-181 development program in May 2012. So far, the drug has not been approved by the FDA or any other regulatory agencies.
Per the company’s press release, approximately 149 million work days are lost every year because of low back pain, with total costs estimated to be $100–200 billion a year. According to a study published in the American Pain Society's The Journal of Pain in Oct 2014, about 19% of the U.S. population was found to be suffering from some type of persistent pain. Hence, approval of the drug will provide the company access to a huge number of patients suffering from the condition in U.S.
However, Nektar is expected to face intense competition in the pain market as several companies are developing pain therapies. Potential competitors include Collegium Pharmaceutical’s (COLL - Free Report) Inc. oxycodone, Pfizer, Inc.’s (PFE - Free Report) tanezumab, Teva Pharmaceutical’s (TEVA - Free Report) naproxen to name a few.
We remind investors that Nektar is also conducting a pivotal human abuse liability study (HAL) for NKTR-181, which is expected to complete enrollment in the first half of 2017. On successful completion of the program, the company will seek a collaboration partner to support the future development and commercialization activities of the drug.
Nektar currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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