See the Study Results

PROVEN EFFECTIVE AND SAFE IN A CLINICAL TRIAL

IGALMI significantly reduced the symptoms of agitation

The study included 378 people with bipolar disorder I or II 380 people with schizophrenia who experienced mild to moderate agitation.

How IGALMI was studied

The main goal was to measure reduction of agitation symptoms 2 hours after taking IGALMI, including:

  • Poor impulse control
  • Tension
  • Hostility
  • Uncooperativeness
  • Excitement

This was measured with the Positive and Negative Syndrome Scale-Excited Component (PEC). Another important goal was to assess IGALMI safety and side effects.

What we learned about IGALMI

IGALMI significantly reduced agitation symptoms,
achieving the main goal of the study.
IGALMI also began reducing agitation symptoms in as early as 20 minutes20 to 30 minutes*
When compared with placebo, the decrease in agitation with IGALMI was statistically significant beginning at 20 minutes after treatment with the 180 mcg dose and 30 minutes after treatment with the 120 mcg dose. This was a key secondary goal of the study. When compared with placebo, the decrease in agitation with IGALMI was statistically significant beginning 20 minutes after treatment with both 120 mcg and 180 mcg doses. This was a key secondary goal of the study.
IGALMI also improved agitation in nearly 4 out of 5 people within 2 hours†
88.8% of patients treated with IGALMI 180 mcg and 79.1% of patients treated with IGALMI 120 mcg experienced at least a 40% reduction in agitation as measured by their total PEC score. 40.5% of patients taking placebo experienced at least a 40% reduction as well. This was another goal of the study. 90.5% of patients treated with IGALMI 180 mcg and 77% of patients treated with IGALMI 120 mcg experienced at least a 40% reduction in agitation as measured by their total PEC score. 46% of patients taking placebo experienced at least a 40% reduction as well. This was another goal of the study.

What we learned about IGALMI safety

There are side effects that you may experience when taking IGALMI.

The most common side effects that occurred in 5% or more of people taking IGALMI in clinical studies included:

  • Sleepiness/drowsiness
  • Prickling or tingling sensation or numbness of the mouth
  • Dizziness
  • Low blood pressure
  • Low blood pressure upon standing
  • Dry mouth

The majority of side effects were mild to moderate in severity.

These are not all the possible side effects of IGALMI. See additional possible side effects in the Important Safety Information below.

Speak with your healthcare provider for medical advice about side effects.

IGALMI is not a controlled substance.
Physical dependence, withdrawal symptoms (eg, nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours.

What should I avoid after taking IGALMI?

Because IGALMI may make you drowsy, you should not perform activities that require mental alertness (like operating a motor vehicle or other hazardous machinery) for at least 8 hours after taking IGALMI.

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IMPORTANT SAFETY INFORMATION

IGALMI can cause serious side effects, including:
  • Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor your vital signs (like blood pressure and heart rate) and alertness after you take IGALMI to prevent you from falling or fainting. Make sure you are adequately hydrated and sit or lie down after taking IGALMI. Tell your healthcare provider if you feel dizzy, lightheaded, or faint.

WHAT IS IGALMI?

IGALMI™ (dexmedetomidine) sublingual film is a prescription medicine that is placed under your tongue or behind your lower lip and is used for the acute treatment of agitation associated with bipolar disorder I or IIschizophrenia in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children.

  • Heart rhythm changes (QT interval prolongation). You should not take IGALMI if you have an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, and if you are taking other drugs that affect your heart rhythm. Taking IGALMI if you have a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Tell your healthcare provider immediately if you feel faint or have heart palpitations.
  • Sleepiness/drowsiness. Do not do activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI.
  • Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours.

The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing.

These are not all the possible side effects of IGALMI. Speak with your healthcare provider for medical advice about side effects.

Tell your healthcare provider about your medical history, including if you suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. Tell your healthcare provider if you are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any drugs that lower your blood pressure, change your heart rate, or take anesthetics, sedatives, hypnotics, and opioids.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or medinfo@bioxceltherapeutics.com.

Please see full Prescribing Information.

WHAT IS IGALMI?

IGALMI™ (dexmedetomidine) sublingual film is a prescription medicine that is placed under your tongue or behind your lower lip and is used for the acute treatment of agitation associated with bipolar disorder I or IIschizophrenia in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children.