April 5 Allergan plc said on Wednesday
that its Botox blockbuster wrinkle treatment just missed
achieving a significant improvement in treating depression in a
mid-stage trial, but it found the data encouraging enough to
move into larger Phase III testing.
Allergan said results from the trial on the lower of two
tested doses compared with placebo were close to what has been
seen with more traditional antidepressants on the market and
consistent with what had been reported from earlier, smaller
Botox depression trials conducted by independent researchers.
"We are encouraged by these data and the potential impact on
adults with major depressive disorder," Allergan research chief
David Nicholson said in a statement. "We plan to move forward
and develop a Phase 3 program for a potential new treatment
option for patients."
While erasing facial wrinkles remains the best known use for
Botox and accounted for roughly half of its global sales of
$2.78 billion in 2016, Allergan has continually tested the drug
for a wide variety of medical conditions.
Among the already approved medical uses for Botox are
chronic migraine, overactive bladder, severe underarm sweating,
eyelid spasms and limb spasticity.
The drug, given through a series of facial injections, just
missed achieving a statistically significant improvement
compared with placebo on the lower of two tested doses as
measured by change from baseline at week 6 in the
Montgomery-Asberg Depression Rating Scale (MADRS), the company
In the 258-patient trial, Botox was tested in adult females
suffering from major depressive disorder. The 30-unit dose
lowered the MADRS score by 3.6 points at week 6 compared with
placebo. The 50-unit dose failed to show a difference from
placebo, but both were well tolerated, the company said.
Allergan believes that by modifying facial expression and
muscle contractions via Botox injections, there may also be a
modification of brain circuitry at work in depression.
In designing larger Phase III trials, Allergan hopes it can
better control for any placebo effect common in depression
trials and demonstrate a more clearly significant result for
Botox after the near miss, Mitchell Brin, Allergan's chief
scientific officer for Botox, said in a telephone interview.
(Reporting by Bill Berkrot; Editing by Leslie Adler)