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The FDA on Aug. 19 approved the first and only rapid-acting oral drug for major
depressive disorder (MDD), a treatment that is being hailed by its
manufacturer as a “potential game-changer” for people struggling with the
difficult-to-treat condition. One pharma analyst expressed optimism about the
drug’s ability to disrupt the MDD treatment market. However, experts from the
PBM sector predict that payers may not embrace the drug warmly given how many
generics are available to treat depression.
Auvelity’s place in the
market is uncertain
- Auvelity
(dextromethorphan HBr-bupropion HCl) is the only N-methyl D-aspartate
(NMDA) receptor antagonist approved for treating MDD, with “labeling of
statistically significant antidepressant efficacy compared to placebo
starting at one week,” according to its manufacturer, Axsome
Therapeutics, Inc.
- Robert Kinyua,
senior director of clinical program development at Prime Therapeutics
LLC, says it’s too soon to tell how much of an impact Auvelity will have
on the MDD treatment landscape.
- “Auvelity was
evaluated in relatively short studies and is not yet included in major
MDD treatment guidelines,” he tells AIS Health. “While it offers a new
combination treatment option within MDD, its place in therapy and uptake
has yet to be determined.”
- “The focus here
is potential,” weighs in Mesfin Tegenu, CEO and chairman of RxParadigm.
“Auvelity is promoted as a first-line agent in which benefits can be
seen within a week compared to traditional therapies that can take an
average of six to eight weeks. However, given that much is not known of
the NMDA pathway, there may be reservation to immediately prescribe
Auvelity.”
At least one analyst is
optimistic for the drug’s uptake
- The FDA’s
approval of the drug wasn’t guaranteed, SVB Securities analysts pointed
out in an Aug. 21 note to investors. “This is clearly long-awaited great
news for the company following the significant delay vs. its prior PDUFA
date of August 2021,” they wrote, referring to deadlines for the FDA to
review new drugs.
- Ultimately, “we
remain optimistic that Auvelity will become a notable product in the
large major depressive disorder (MDD) market” due to its novel mechanism
of action, its ability to rapidly ease symptoms and its safety profile,
the SVB Securities analysts wrote.
- Auvelity’s manufacturer
expects to commercially launch the drug in the fourth quarter of 2022.
Ultimately, “given availability of generic, guideline-recommended
antidepressants, health plans may apply utilization management (UM) to
Auvelity as has been the case with other branded MDD treatments,” Kinyua
says.
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