Nektar Therapeutics (NASDAQ:NKTR)’ NKTR-181, an opioid-based painkiller, has met both the secondary and the primary endpoints in its late-stage study. In the third phase trial, 600 patients who were suffering from chronic back pain with symptoms that ranged between moderate and severe participated. The participants in the phase 3 study were opioid-naïve (had never used opioids previously).
Drug efficacy
In the end it was found that participants who were took a dose of NKTR-181 twice a day experienced pain relief in comparison to patients who took a placebo. The efficacy of NKTR-181 in relieving pain was most noticeable in the 12th week of the study. Other areas that NKTR-181 performed well in was in tolerability and safety. Some of the adverse events that were experienced by participants included nausea and constipation though it was only by a small number.
Opioid abuse
According to Nektrar Therapeutics, NKTR-181 can lead to pain relief in patients suffering from unending lower back pain without putting those patients at risk of addiction. What helps in preventing abuse of the pain killer despite being opioid-based is its ability to only seep slowly into the brain as opposed to a faster absorption rate of other opioid-based painkillers. This is comforting given the high rate of opioid abuse in the United States with approximately 91 Americans dying daily from opioid abuse.
“Given the seriousness of the current opioid epidemic in the U.S. and the significant number of people battling chronic pain, we are committed to bringing this new molecule to patients and physicians as quickly as possible,” Nektar Therapeutics’ chief executive officer, Howard Robin, said.
Crowded field
If NKTR-181 is approved, it will find a crowded market of painkillers that are based on opioid. Some were approved by the U.S. Food and Drug Administration only and this includes Arymo ER which was developed by Egalet Corp and which got FDA’s approval earlier in the year. There is also Rexista which was developed by IntellipharmaceCeutics International and which was approved in early February by the Food and Drug Administration.
In the pre-market trading hours, shares of Nektar Therapeutics stood at $22.11.