The federal government approved Vortioxetine for the
treatment of adults with major depressive disorder in September 2013, and the
medication is available in pharmacies across the United States (U.S.) since
beginning of 2014 as prescription drug. The commercial name of Vortioxetine, a
variant on serotonin reuptake inhibitors that are the mainstay of depression
treatment, is Brintellix.
About Brintellix
(vortioxetine)
The mechanism of the antidepressant effect of Brintellix is
not fully understood yet. It is an inhibitor of serotonin (5-HT) reuptake and
that is considered to be a mechanism of its action. It is also an agonist at
5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at
5-HT3, 5-HT1D and 5-HT7 receptors. The contribution of each of these activities
to Brintellix’s antidepressant effect has not been established. It is
considered to be the first and only compound with this combination of
pharmacodynamic activity.
The World Health Organization has issued an Anatomical
Therapeutic Chemical (ATC) code for Brintellix that places it in the category
of “Other” antidepressants.
The most commonly observed adverse events in MDD patients
treated with Brintellix in 6-8 week placebo-controlled studies (incidence
greater than or equal to 5 percent and at least twice the rate of placebo) were
nausea, constipation and vomiting. Overall, 5 to 8 percent of the patients who
received Brintellix 5 to 20 mg/day in short-term trials discontinued treatment
due to an adverse reaction, the most common being nausea, compared with 4
percent of placebo-treated patients in these studies. Brintellix and other
antidepressants may cause serious side effects.
In clinical studies, Brintellix had no significant effect on
body weight as measured by the mean change from baseline in 6-8 week
placebo-controlled studies. In the 6-month, double-blind, placebo-controlled
phase of a long-term study in patients who had responded to Brintellix during
the initial 12-week, open-label phase, there was no significant effect on body
weight between Brintellix and placebo-treated patients. Brintellix has not been
associated with any clinically significant effects on vital signs, including
systolic and diastolic blood pressure and heart rate, as measured in
placebo-controlled studies.
The recommended starting dose of Brintellix is 10 mg once
daily without regard to meals. The dose should then be increased to 20 mg/day,
as tolerated, because higher doses demonstrated better treatment effects in
trials conducted in the U.S. A dose decrease down to 5 mg/day may be considered
for patients who do not tolerate higher doses. The available doses provide
important flexibility for physicians to help address the variability of patient
needs.
Brintellix is available as 5 mg, 10 mg and 20 mg tablets.
Key Clinical Trials
In five short-term studies of 6 to 8 weeks—including a
dedicated study with older adults—vortioxetine was effective in treating
depression, demonstrating statistically significant improvements in overall
symptoms compared with placebo. The primary efficacy measure was mean change from
baseline to endpoint in the Hamilton Depression Scale total score in two
short-term studies, including the study of older adults, and the
Montgomery–Asberg Depression Rating Scale total score in the other
studies.
In addition, the clinical trial program included a 24- to
64-week long-term maintenance study in which vortioxetine treatment resulted in
a statistically significant longer time to recurrence of depressive episodes
compared with placebo. Studies evaluated for safety included more than 4,700 patients
aged 18 to 88 years.
Important Safety
Information
Suicidal Thoughts and
Actions and Antidepressant Drugs
Antidepressants may
increase suicidal thoughts or actions in some children, teens or young adults
within the first few months of treatment or when the dose is changed.
Depression or other serious mental illnesses are the most important causes of
suicidal thoughts or actions. People who have (or have a family history of)
bipolar illness, or suicidal thoughts or actions may have a particularly high
risk. Pay close attention to any changes, especially sudden changes in mood,
behavior, thoughts or feelings. Call your healthcare provider right away, if
symptoms such as anxiety, irritability, impulsivity, trouble sleeping,
aggressive behavior or suicidal thoughts are new, worse or worry you. Brintellix
has not been evaluated for use in patients under 18.
Do not take Brintellix if you:
- Are
allergic to vortioxetine or any of the ingredients in Brintellix
- Take a
Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or
pharmacist if you are not sure if you take an MAOI, including the
antibiotic linezolid; do not take an MAOI within 21 days of stopping Brintellix;
do not start Brintellix if you stopped taking an MAOI in the last14 days
BRINTELLIX may cause serious side effects including:
* Serotonin Syndrome: A potentially life-threatening problem
that can happen when medicines such as Brintellix are taken with certain other
medicines. Symptoms may include agitation, hallucinations, coma or other
changes in mental status; problems controlling movements or muscle twitching,
stiffness or tightness; fast heartbeat, high or low blood pressure; sweating or
fever; nausea, vomiting or diarrhea.
* Abnormal bleeding or bruising: Brintellix and
other serotonergic antidepressant medicines may increase your risk of bleeding
or bruising, especially if you take the blood thinner warfarin (Coumadin,
Jantoven), a non-steroidal anti-inflammatory drug (NSAID), or
aspirin.
* Manic episode: Symptoms may include greatly
increased energy; severe trouble sleeping; racing thoughts; reckless behavior;
unusually grand ideas; excessive happiness or irritability; talking more or
faster than usual.
* Visual problems: May include eye pain, changes
in vision, swelling or redness in or around the eye. Only some people are at
risk for these problems. You may want to undergo an eye examination to see if
you are at risk and receive preventative treatment if you are.
* Low salt (sodium) levels in the blood: Symptoms
may include headache; difficulty concentrating, memory changes or confusion;
weakness and unsteadiness on your feet; and in severe or sudden cases
hallucinations, fainting, seizures or coma. If not treated, severe low sodium
levels can cause death.
Before starting Brintellix, tell your healthcare provider
if you have or had liver problems, seizures or convulsions, bipolar
disorder (manic depression) or mania, low salt (sodium) levels in your blood,
bleeding problems, drink alcohol, have any other medical conditions or if you
are pregnant, nursing, plan to become pregnant, or plan to nurse.
Brintellix and some medicines may interact with each
other, may not work as well, or may cause serious side effects when taken
together. Tell your healthcare provider if you plan on or are taking
any other prescription and non-prescription medicines, vitamins and
herbal supplements including medicines for migraine headaches, such as
triptans; medicines used to treat mood, anxiety, psychotic or thought disorders
such as tricyclics, lithium, SSRIs, SNRIs, bupropion, buspirone or
antipsychotics; MAOIs including linezolid (a specific antibiotic); over-the-countersupplements
such as tryptophan or St. John's wort; and the following medicines:
aspirin, NSAIDs, warfarin (Coumadin, Jantoven), diuretics, rifampicin,
carbamazepine, phenytoin, quinidine, tramadol or fentanyl.
Common side effects of Brintellix include: nausea,
constipation or vomiting. These are not all the possible side effects of
BRINTELLIX.
Do not start or stop taking Brintellix without talking to
your healthcare provider first. Suddenly stopping Brintellix when you
take higher doses may cause you to have side effects including headache, stiff
muscles, mood swings, sudden outbursts of anger, dizziness or feeling
lightheaded, or runny nose.
Until you know how Brintellix affects you, do not drive,
operate heavy machinery or engage in other dangerous activities.
Avoid drinking alcohol while taking Brintellix.
Talk to your healthcare provider.
Summary
Vortioxetine represents a new class of antidepressant. It
has multiple actions that enhance serotonergic activity. This appears to have
“knock-on” effects on other neurotransmitters implicated in the causation and
maintenance of depressive disorders. Vortioxetine is well tolerated and appears
to have relatively little potential for adverse drug interactions. Clinical
studies indicate that it is effective in the treatment of major depression.
Though there is no suggestion of superiority over active comparators (and some
suggestion that SNRIs may show greater efficacy), most studies suggest that
there is a clinically meaningful advantage in terms of tolerability. Incidence
of sexual side effects appears particularly low. Older people tolerate
vortioxetine well, and there is some evidence that it may have cognitive
benefits.
Brintellix is a very promising drug in treating major
depression. It is different from the other types of drugs used to treat
depression and it works using two mechanisms of action, which are: a) receptor
activity modulation and b) reuptake inhibition. Thus, this drug is a much more
improved version of the first line agents used to treat the psychiatric
disorder. However, it does not necessarily follow that because this drug is
new, it is already effective. This product still has a lot to prove to the
public in the following years. As of the moment, until further confirmation
from public reviews about the effectiveness of this product has been published,
it is wise to stick to what professionals already trust.
Sources and Additional
Information:
