Nektar stock reaches new highs on pain drug results
- Nektar Therapeutics' stock surged upwards more than 40% in value Monday as positive Phase 3 results for its opioid painkiller candidate boosted optimism in the drug's prospects for approval.
- Known as NKTR-181, Nektar's analgesic hit both its primary and secondary endpoints, showing a statistically significant improvement in chronic back pain relief compared with placebo among patients who were new to opioid therapy.
- Nektar also touted the drug's lack of abuse potential, a key worry surrounding new opioid drugs as abuse and overdose rates continue to climb in many U.S. states. NKTR-181 is specifically designed to have low permeability across the blood-brain barrier, potentially limiting the drug's effect on the brain.
Opioid medications are effective in pain relief, but drug overdose deaths involving prescription opioids have quadrupled since 1999, according to the Centers for Disease Control and Prevention (CDC). More than 15,000 Americans died from prescription opioid overdoses last year.
In response to growing scrutiny of the drug industry's role in the crisis, pharmaceuticals companies have been developing so-called abuse-deterrent opioids, designed to be harder crush or dissolve and therefore more difficult. to abuse. The reformulated opioids aren't perfect, though, and the Food and Drug Administration has asked drugmakers to conduct long-term studies to assess the real-world effectiveness of abuse-deterrence.
Some of the optimism around Nektar's results involves its pharmacokinetic design that could make it less habit-forming regardless of ingestion method.
Analysts at Jefferies suggest the drug could become Nektar's largest product because of how it could address the challenges of opioid abuse. Previously discounted for a Phase 2 failure in 2013, the drug now appears on track for a submission to the FDA by late 2019, Jefferies said.
In addition to meeting the study's primary endpoint, NKTR-181 also met secondary objectives measuring the proportion of patients reporting pain reductions greater than 30% or 50, compared to placebo.
NKTR-181's lack of abuse potential is supported by a separate study published this month in the journal Pain Medicine. This study looked at a range of doses of NKTR-181 in 42 people who had reported recreational opioid use. All doses of NKTR-181 were rated similarly to placebo in "drug liking" and "feeling high" scores, with only the 400 mg dose showing some differentiation. Scores for each dose were significantly lower compared to 40 mg oxycodone.
Nektar's CEO Howard Rubin has said the company intends to out-license the drug to a company with a "strong presence" in the pain market. Monday's results could make such a move much more lucrative.
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