* Drug outperforms placebo, meets goals in study
* Drug designed to be much safer than standard opioids
* Co to discuss next steps with FDA, looks for strategic
* Shares jump 19 pct premarket
(Adds details, shares)
By Natalie Grover
March 20 Nektar Therapeutics said its
experimental opioid, designed to achieve pain relief without the
euphoria that can lead to abuse and addiction, succeeded in a
key late-stage study.
The company's stock jumped about 19 percent to $19.50 in
premarket trading on Monday.
U.S. regulators and lawmakers are taking steps to control
the supply of opioids as the country remains engulfed in an
epidemic of abuse, overdose and addiction.
This is partly due to the unrestricted prescription of
narcotic painkillers, drug diversion, and the paucity of access
to substance-abuse treatment programs. Everyday, 91 Americans
die of opioid overdose, the U.S. Centers for Disease Control and
Prevention (CDC) estimates.
Nektar's drug, which by design reaches the brain slower than
existing opioids to deter abuse, outperformed a placebo in over
600 patients with chronic lower back pain.
Nektar's NKTR-181 is as effective as existing long-acting
opioids and was created drawing on science that suggests the
euphoric effect of opioids is influenced by their rate of entry
into the brain, Chief Scientific Officer Dr. Stephen Doberstein
It is the same concept that underlies nicotine and cocaine
addiction, he said. "The faster the drug enters the brain,
across the blood-brain barrier, the more dopamine is released."
NKTR-181's characteristics are independent of the
formulation, Doberstein added. "It doesn't really matter if you
snort it or inject it."
A separate "human abuse liability" study showed the drug is
"virtually indistiguishable" from placebo in subjects who are
well versed in understanding what an opioid feels like from an
abusers standpoint, he added.
Opioids are considered the gold standard in treating chronic
pain that persists despite other forms of therapy, but the
rising wave of abuse is taking a toll on the healthcare system.
Last week, an independent panel to the FDA concluded the
benefits of a long-acting opioid painkiller, Opana ER, sold by
Endo International Plc no longer outweighed its risks.
The panel was asked to address the high abuse rate of the
this variation of oxymorphine — and other related products.
Under the Controlled Substance Act, which organizes drugs
into groups based on risk of abuse or harm, most opioids come
under a schedule II category. But Nektar hopes NKTR-181 is safe
enough to secure a schedule III, or lower, classification.
The company plans to go to the U.S. Food and Drug
Administration to discuss its next steps and is looking for a
partner to sell the drug, if and when approved, Doberstein said.
(Reporting by Natalie Grover in Bengaluru; Editing by Anil