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Drug Trials Snapshots: SUNOSI

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the SUNOSI Package Insert for complete information.

SUNOSI (solriamfetol)
suh-NOH-see
Jazz Pharmaceuticals, Inc
Approval date: March 20, 2018


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

SUNOSI is a drug used to improve wakefulness in adults with narcolepsy or obstructive sleep apnea (OSA).

Narcolepsy is a sleep disorder with excessive daytime drowsiness and sudden attacks of sleep. Obstructive sleep apnea (OSA) is a sleep disorder with frequent sleep disruptions because of the blocked the airway. This leads to poor sleep and daytime drowsiness.

How is this drug used?

SUNOSI is a tablet that is taken by mouth once a day. The dose may be adjusted, and the dose range depends on whether the drug is taken for narcolepsy or OSA.

Patients who have OSA should continue modalities to treat airway obstruction while taking SUNOSI.

What are the benefits of this drug?

Patients treated with SUNOSI remained awake longer and had decreased daytime sleepiness compared with patients treated with placebo.

What are the benefits of this drug (results of trials used to assess efficacy)?

The tables below summarize efficacy results for the evaluated patients in clinical trials 1 and 2. The co-primary endpoints were the change from baseline in MWT and ESS score at Week 12.

Table 2. Maintenance of Wakefulness Test (minutes) in Patients with Narcolepsy (Trial 1) and OSA (Trial 2)

Indication/Trial Treatment Group (N) Mean Baseline Score (SD) LS Mean Change from Baseline at Week 12 (SE) Difference from Placebo (95% CI)
Narcolepsy
Trial 1
Placebo (58) 6.2 (5.7) 2.1 (1.3) -
SUNOSI 75 mg (59) 7.5 (5.4) 4.7 (1.3) 2.6 (-1.0, 6.3)
SUNOSI 150 mg* (55) 7.9 (5.7) 9.8 (1.3) 7.7 (4.0, 11.3)
OSA
Trial 2
Placebo (114) 12.6 (7.1) 0.2 (1.0) -
SUNOSI 37.5 mg* (56) 13.6 (8.1) 4.7 (1.4) 4.5 (1.2, 7.9)
SUNOSI 75 mg* (58) 12.4 (6.9) 9.1 (1.4) 8.9 (5.6, 12.4)
SUNOSI 150 mg* (116) 12.5 (7.2) 11.0 (1.0) 10.7 (8.1, 13.4)

SD = standard deviation; SE = standard error; LS Mean = least square mean; CI = confidence interval
Maximum possible MWT score is 40 minutes. A positive change represents improvement
Difference from Placebo = LS Mean Difference between change from baseline between active drug and placebo.
* Dose that was statistically significantly superior to placebo after adjusting for multiplicity.

SUNOSI Prescribing Information

Table 3. Epworth Sleepiness Scale in Patients with Narcolepsy (Trial 1) and OSA (Trial 2)

Indication/Trial Treatment Groups (N) Mean Baseline Score (SD) LS Mean Change from Baseline at Week 12 (SE) Difference from Placebo (95% CI)
Narcolepsy
Trial 1
Placebo (58) 17.3 (2.9) -1.6 (0.7) -
SUNOSI 75 mg (59) 17.3 (3.5) -3.8 (0.7) -2.2 (-4.0, -0.3)
SUNOSI 150 mg* (55) 17.0 (3.6) -5.4 (0.7) -3.8 (-5.6, -2.0)
OSA
Trial 2
Placebo (114) 15.6 (3.3) -3.3 (0. 5) -
SUNOSI 37.5 mg* (56)
SUNOSI 75 mg* (58)
15.1 (3.5)
15.0 (3.5)
-5.1 (0.6)
-5.0 (0.6)
-1.9 (-3.4, -0.3)
-1.7 (-3.2, -0.2)
SUNOSI 150 mg* (116) 15.1 (3.4) -7.7 (0.4) -4.5 (-5.7, -3.2)

SD = standard deviation; SE = standard error; LS Mean = least square mean; CI = confidence interval
Scores range from 0 to 24 with higher scores indicating more severe sleepiness. A negative change represents improvement.
Difference from placebo = LS mean difference between change from baseline between SUNOSI and placebo.
* Dose that was statistically significantly superior to placebo after adjusting for multiplicity.

SUNOSI Prescribing Information

Maintenance of effect was assessed in Trials 3 and 4.The results are presented below.

Table 4. Efficacy Results from Randomized Withdrawal Trials in Patients with Narcolepsy and OSA in Trials 3 and 4

Indication/Trial Endpoint Treatment Groups (N) Beginning of Randomized Withdrawal Period (Baseline)
Mean (SD)
LS Mean Change from Baseline (SE) Difference from Placebo (95% CI)
  OSA
Trial 3
MWT (minutes) Placebo (62)
SUNOSI* (60)
29.0 (9.9)
31.7 (9.2)
-12.1 (1.3)
-1.0 (1.4)
  11.2 (7.8, 14.6)
ESS Score Placebo (62)
SUNOSI* (60)
5.9 (3.8)
6.4 (4.4)
 4.5 (0.7)
-0.1 (0.7)
  -4.6 (-6.4, -2.8)
  OSA and Narcolepsy
Trial 4  
ESS Score Placebo (141)
SUNOSI* (139)
7.8 (5.0)
7.3 (5.3)
5.3 (0.4)
1.6 (0.4)
  -3.7 (-4.8, -2.7)

SD = standard deviation; SE = standard error; LS Mean = least square mean; CI = confidence interval
For MWT, maximum possible score is 40 minutes; positive changes indicate improvement.
For ESS, scores range from 0 to 24; negative changes indicate improvement.
* Statistically significantly superior to placebo after adjusting for multiplicity

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: SUNOSI worked similarly in men and women.
  • Race: The majority of patients were White. The number of patients in other races was limited; therefore, differences in how well the drug worked among other races could not be determined.
  • Age: SUNOSI worked similarly in patients younger and older than 65 years of age.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?

The tables below summarize efficacy results by sex, race and age in individual Trials 1 and 2.

Table 5. Subgroup Analysis Results on MWT - Trial 1

Dose(mg) Subgroup SUNOSI
LS Mean (SE) (n)
Placebo
LS Mean (SE) (n)
LS Mean Difference (SE) SUNOSI-Placebo
75 Sex
Men 3.7 (2.12) (20) 4.3 (2.01) (22) -0.6 (2.93)
Women 5.2 (1.73) (34) 0.6 (1.69) (34) 4.6 (2.42)
Race
White 4.9 (1.54) (42) 2.0 (1.47) (44) 2.9 (2.13)
Other 4.3 (2.80) (12) 2.1 (2.80) (12) 2.2 (3.93)
150 Sex
Men 7.3 (2.33) (15) 4.3 (2.01) (22) 3.0 (3.08)
Women 11.0 (1.63) (37) 0.6 (1.69) (34) 10.3 (2.36)
Race
White 10.0 (1.52) (41) 2.0 (1.47) (44) 8.1 (2.13)
Other 9.1 (2.85) (11) 2.1 (2.80) (12) 7.0 (3.94)

FDA Review

Table 6. Subgroup Analysis Results on ESS - Trial 1

Dose (mg) Subgroup SUNOSI
LS Mean (SE) (n)
Placebo
LS Mean (SE) (n)
LS Mean Difference (SE)
SUNOSI-Placebo
75 Sex
Men -3.1 (1.00) (22) -3.2 (0.96) 24 0.1 (1.39)
Women -4.2 (0.86) (37) -0.7 (0.85) (34) -3.6 (1.21)
Race
White -3.5 (0.69) (46) -2.1 (0.66) (46) -1.4 (0.95)
Other -5.1 (1.94) (13) 0.3 (2.03) (12) -5.4 (2.80)
150 Sex
Men -2.9 (1.11) (16) -3.2 (0.96) (24) 0.3 (1.48)
Women -6.5 (0.81) (39) -0.7 (0.85) (34) -5.8  (1.18)
Race
White -5.6 (0.68) (44) -2.1 (0.66) (46) -3.5 (0.95)
Other -4.9. (1.99) (11) 0.3 (2.03) (12) -5.2 (2.82)

FDA Review

Table 7. Subgroup Analysis Results on MWT - Trial 2

Dose (mg)   Subgroup SUNOSI
LS Mean (SE) (n)
Placebo
LS Mean (SE) (n)
LS Mean Difference (SE) SUNOSI-Placebo
37.5 Sex
  Men 3.9 (1.78) (33) 0.5 (1.28) 70 3.4 (2.16)
  Women 6.3 (2.35) (19) -0.3 (1.61) (39) 6.5 (2.83)
Race
  White 3.1 (1.57) (41) -0.2  (1.16) (79) 3.3 (1.93)
  Other 10.1 (3.22) (11) 1.0 (1.96) (30) 9.1 (3.75)
  Age Group (years)
  < 65 5.0 (1.62) (39) 0.1 (1.13) (86) 4.9 (1.96)
  > 65 3.3 (2.97) (13) 0.1 (2.18) (23) 3.2 (3.60)
75 Sex
  Men 7.1 (1.84) (30) 0.5 (1.28) (70) 6.6 (2.21)
  Women 11.5 (2.00) (25) -0.3 (1.61) (34) 11.8  (2.55)
Race
  White 8.5 (1.57) (40) -0.2  (1.16) (79) 8.7 (1.92)
  Other 10.2 (2.77) (15) 1.0 (1.96) (39) 9.1 (3.37)
Age Group (years)
  < 65 9.3 (1.52) (44) 0.1 (1.13) (86) 9.1 (1.88)
  > 65 7.3 (3.12) (11) 0.1 (2.18) (23) 7.2 (3.68)
150 Sex
  Men 9.8 (1.23) (69) 0.5 (1.28) (70) 9.3 (1.74)
  Women 13.0 (1.58) (42) -0.3 (1.61) (39) 13.3 (2.24)
Race
  White 11.0 (1.07) (89) -0.2 (1.16) (79) 11.2 (1.54)
  Other 10.2 (2.40) (22) 1.0 (1.96) (30) 9.2 (3.11)
Age Group (years)
  < 65 11.4 (1.03) (100) 0.1 (1.13) (86) 11.3 (1.51)
  > 65 7.1 (3.02) (11) 0.1 (2.18) (23) 7.0 (3.65)

FDA Review

Table 8. Subgroup Analysis Results on ESS - Trial 2

Dose (mg)   Subgroup SUNOSI
LS Mean (SE) (n)
Placebo
LS Mean (SE) (n)
LS Mean Difference (SE) SUNOSI-Placebo
37.5 Sex
  Men -4.5 (0.80) (37) -3.6 (0.58) (73) -0.9 (0.97)
  Women -6.5 (1.07) (19) -2.6 (0.72) (41) -3.9 (1.28)
Race
  White -4.9 (0.72) (43) -3.1 (0.53) (82) -1.7 (0.88)
  Other -5.8 (1.33) (13) -3.3 (0.82) (32) -2.4 (1.56)
Age Group (years)
  < 65 -5.4 (0.75) (42) -3.3 (0.52) (90) -2.0 (0.90)
  > 65 -4.5 (1.17) (14) -2.9 (0.87) (24) -1.5 (1.42)
75 Sex
  Men -4.5 (0.84) (33) -3.6 (0.58) (73) -0.8 (1.00)
  Women -5.7 (0.91) (25) -2.6 (0.72) (41) -3.1 (1.15)
Race
  White -5.3 (0.72) (43) -3.1 (0.53) (82) -2.2 (0.88)
  Other -3.8 (1.16) (15) -3.3 (0.82) (32) -0.5 (1.42)
Age Group (years)
  < 65 -4.7 (0.71) (46) -3.3 (0.52) (90) -1.4 (0.87)
    > 65 -5.7 (1.26) (12) -2.9 (0.87) (24) -2.8 (1.47)
150 Sex
  Men -7.8 (0.56) (72) -3.6 (0.58) (73) -4.1 (0.79)
  Women -7.7 (0.70) (44) -2.6 (0.72) (41) -5.1 (1.00)
Race
  White -7.4 (0.49) (93) -3.1 (0.53) (82) -4.2 (0.70)
  Other -8.1 (0.98) (23) -3.3 (0.82) (32) -4.8 (1.28)
Age Group (years)
  < 65 -7.7 (0.48) (105) -3.3 (0.52) (90) -4.4 (0.69)
  > 65 -7.5 (1.23) (11) -2.9 (0.87) (24) -4.6 (1.48)

FDA Review

What are the possible side effects?

SUNOSI can cause serious side effects including increases in blood pressure and heart rate that may increase the risk of cardiovascular diseases. SUNOSI may worsen symptoms of psychiatric diseases.

The most common side effects of SUNOSI are headache, nausea, decreased appetite, difficulty sleeping and anxiety.

What are the possible side effects (results of trials used to assess safety)?

The tables below summarize adverse reactions in patients with narcolepsy and OSA in the combined three trials (safety population).

Table 9. Adverse Reactions ≥ 2% in Patients Treated with SUNOSI and Greater than Placebo in Pooled 12 Week Placebo Controlled Clinical Trials in Narcolepsy (75 mg and 150 mg)

  Narcolepsy
System Organ Class
 
Placebo
N = 108
(%)
SUNOSI
N = 161
(%)
Metabolism and Nutrition Disorders
Decreased appetite 1 9
Psychiatric Disorders
Insomnia* 4 5
Anxiety* 1 6
Nervous System Disorders
Headache* 7 16
Cardiac Disorders
Palpitations 1 2
Gastrointestinal Disorders
Nausea* 4 7
Dry mouth 2 4
Constipation 1 3

Table 10. Adverse Reactions ≥ 2% in Patients Treated with SUNOSI and Greater than Placebo in Pooled 12 Week Placebo Controlled Clinical Trials in OSA (37.5 mg, 75 mg, and 150 mg)

  OSA
System Organ Class Placebo
N = 118
(%)
SUNOSI
N = 235
(%)
Metabolism and Nutrition Disorders
Decreased appetite 1 6
Psychiatric Disorders
Anxiety* 1 4
Irritability 0 3
Nervous System Disorders
Dizziness 1 2
Cardiac Disorders
Palpitations 0 3
Gastrointestinal Disorders
Nausea* 6 8
Diarrhea 1 4
Abdominal pain* 2 3
Dry mouth 2 3
General Disorders and Administration Site Conditions
Feeling jittery 0 3
Chest discomfort 0 2
Skin and Subcutaneous Tissue Disorders
Hyperhidrosis 0 2

*“Anxiety” includes anxiety, nervousness, and panic attack; “Nausea” includes nausea and vomiting; “Abdominal pain” includes abdominal pain, abdominal pain upper, and abdominal discomfort.

SUNOSI Prescribing Information

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar between men and women.
  • Race: The majority of patients were White. The occurrence of side effects was similar among White and Black or African American patients. The number of patients in other races was limited; therefore, differences in the occurrence of side effects among other races could not be determined.
  • Age: The occurrence of side effects was similar between patients younger and older than 65 years of age.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The table below summarizes the occurrence of the most common adverse reaction, headache, by subgroup.

Table 11. Subgroup Analysis of Headache (safety population)

Demographic Characteristics SUNOSI
n/N (%)
Placebo
n/N (%)
Sex, n (%)
Men 12/197 (6.1) 7/119 (5.9)
Women 33/199 (16.6) 13/107 (12.1)
Race, n (%)
White 32/307 (10.4) 17/173 (9.8)
Black or African American 9/69 (13.0) 3/45 (6.7)
Asian 2/11 (18.1) 0/4 (0)
Age Group, n (%)
< 65 years 42/351 (12.0) 19/197 (9.6)
> 65 years 3/45 (6.7) 1/29 (3.4)

Clinical Trial Data

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved SUNOSI based primarily on evidence from five clinical trials (Trial 1/NCT02348593, Trial 2/NCT02348606, Trial 3/NCT02348619, Trial 4/NCT02348632, Trial 5 NCT01681121) of 622 patients with narcolepsy or obstructive sleep apnea (OSA). The trials were conducted in Canada, Europe, and the United States.

The population that provided data for side effects of SUNOSI (safety population) is presented below.

Figure 1 summarizes how many men and women were in the clinical trials.

Figure 1. Demographics by Sex

Figure 1. Demographics by Sex

FDA Review

Figure 2 summarizes the percentage of patients by race in the clinical trials.

Figure 2. Demographics by Race

Pie chart summarizing the percentage of patients by race enrolled in the clinical trials. In total, 480 White (77%), 114 Black or African American (18%), 15 Asian (3%) and 13 Other patients (2%) participated in the clinical trials.

*Other includes American Indian or Alaska Native and Native Hawaiian or other Pacific Islander

FDA Review

Table 1. Demographics of Trials by Race

Race Number of Patients Percentage of Patients
White 480 77%
Black or African American 114 18%
Asian 15 3%
American Indian or Alaska Native 2 less than 1%
Native Hawaiian or other Pacific Islander 3 less than 1%
Other 8 1%

FDA Review

Figure 3 summarizes the percentage of patients by age in the clinical trials.

Figure 3. Demographics by Age

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trials. In total, 548 patients (88%) were less than 65 years old, and 74 patients (12%) were 65 years and older

FDA Review

Who participated in the trials?

The table below summarizes the demographics of the patients in the clinical trials. The safety population from Trials 1, 2 and 5 is presented.

Table 12. Demographics of Patients in the Clinical Trials (Safety Population)

Demographic Characteristics SUNOSI
N=396
Placebo
N=226
Total
N=622
Sex, n (%)
Men 197 (49.7) 119 (52.7) 316 (50.8)
Women 199 (50.3) 107 (47.4) 306 (49.2)
Race, n (%)
White 307 (77.5) 173 (76.6) 480 (77.2)
Black or African American 69 (17.4) 45 (19.9) 114 (18.3)
Asian 11 (2.8) 4 (1.8) 15 (2.4)
American Indian or Alaskan Native 1 (0.3) 1 (0.4) 2 (0.3)
Native Hawaiian or other Pacific Islander 2 (0.5) 1 (0.4) 3 (0.4)
Other 6 (1.5) 2 (0.9) 8 (1.3)
Age Group (years), n (%)
< 65 years 351 (88.6) 197 (87.2) 548 (88.1)
> 65 years 45 (11.4) 29 (12.8) 74 (11.9)
Age (years)      
Mean (SD) 49.7 (12.9) 45.6 (15.4) 47.6 (14.1)
Median 51.0 48.0 49.0
Range 18, 75 18, 74 18, 75
Ethnicity, n (%)
Hispanic 33 (8.3) 17 (7.5) 50 (8.0)
Not Hispanic 363 (91.7) 209 (92.5) 572 (92.0)
Region, n (%)
USA 351 (88.6) 206 (91.2) 557 (89.5)
Europe 31 (7.8) 11 (4.8) 42 (6.8)
Canada 14 (3.5) 9 (4.0) 23 (3.7)

Clinical Trial Data

How were the trials designed?

The benefits and side effects of SUNOSI were evaluated in five clinical trials. All trials enrolled adults 18 to 75 years old with narcolepsy or OSA who had excessive daytime sleepiness or trouble maintaining wakefulness.

Trial 1 enrolled patients with narcolepsy. Patients were randomized to receive one of two doses of SUNOSI or placebo by mouth once daily for 12 weeks. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of SUNOSI was assessed by determining the difference in Epworth Sleepiness Scale (ESS) and Maintenance of Wakefulness Test (MWT) before and during treatment. The ESS is an 8-item questionnaire where patients rate their perceived likelihood of falling asleep during usual daily life activities. The MWT measures the number of minutes an individual can remain awake during the daytime in a darkened, quiet environment.

Trial 2 enrolled patients with OSA. Patients were randomized to receive one of three doses of SUNOSI or placebo by mouth once daily for 12 weeks. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of SUNOSI was assessed by determining the difference in ESS scores and MWT times before and during treatment.

Trial 3 was a 6-week trial that enrolled patients with OSA. Patients were randomized to receive SUNOSI or placebo. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The data were used to assess continuation of SUNOSI benefit.

Trial 4 was a 52-week trial that included patients with either OSA or narcolepsy who completed prior trials. All patients received SUNOSI for up to 50 weeks. After 6 months of treatment, some patients were randomized to continue SUNOSI or switch to placebo. The data were used to assess continuation of SUNOSI benefit.

Trial 5 was a 12-week trial that enrolled patients with narcolepsy. Patients were randomized to receive SUNOSI or placebo for 12 weeks. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The data were primarily used to assess side effects in addition to data on side effects from Trial 1 and Trial 2.

How were the trials designed?

Five trials were used to assess SUNOSI in adults 18 to 75 years with narcolepsy or OSA and excessive daytime sleepiness. Primary efficacy was evaluated in 2 trials (Trial 1 and Trial 2). Maintenance of effect was assessed in 2 trials (Trial 3 and Trial 4), and safety was primarily assessed in three trials (Trial 1, Trial 2, and Trial 5).

Trial 1 was a randomized, double-blind, placebo-controlled clinical trial that enrolled patients with narcolepsy who met the Diagnostic and Statistical Manual of Mental Disorders criteria (DSM-V) for narcolepsy. Patients had excessive daytime sleepiness based on the Epworth Sleepiness Scale (ESS) with a score > 10 and trouble maintaining wakefulness (mean sleep latency < 10 minutes). Patients in Trial 1 were randomized to receive SUNOSI 75 mg, 150 mg, or placebo by mouth once daily for 12 weeks. The co-primary endpoints were change from baseline in the Maintenance of Wakefulness Test (MWT) and ESS score at Week 12.

Trial 2 was a randomized, double-blind, placebo-controlled clinical trial that enrolled patients with OSA who met the International Classification of Sleep Disorders (ICSD-3), had excessive daytime sleepiness (ESS Score > 10) and trouble maintaining wakefulness (mean sleep latency < 25 minutes). Patients were randomized to receive SUNOSI 37.5 mg, 75 mg, 150 mg, or placebo by mouth. The co-primary endpoints were change from baseline in MWT and ESS score at Week 12.

Trial 3 was a 6-week, double-blind, placebo-controlled, randomized-withdrawal trial that enrolled patients with OSA. During an initial 2-week open label titration phase, patients were titrated to the maximum tolerable SUNOSI dose between 75 mg and 300 mg. Patients continued this dose for 2 weeks. After 2 weeks of stable-dose treatment, patients were randomized to continue SUNOSI or switch to placebo. The endpoints were change from the beginning to the end of the randomized withdrawal period in MWT and ESS.

Trial 4 was a 52-week, open-label clinical trial with a 2-week withdrawal period. The trial enrolled patients with OSA or narcolepsy who had completed a prior trial that assessed SUNOSI. During an initial 2-week open label titration phase, patients were titrated to the maximum tolerable SUNOSI dose between 75 mg and 300 mg. Patients continued this dose for up to 50 weeks. After 6 months of stable-dose treatment, some patients were randomized to continue SUNOSI or switch to placebo. The endpoint was change from the beginning to the end of the randomized withdrawal period in ESS.

Trial 5 was a 12-week, randomized, double-blind, placebo-controlled clinical trial that enrolled patients with narcolepsy who met the Diagnostic and Statistical Manual of Mental Disorders criteria (DSM-V) for narcolepsy. Patients had excessive daytime sleepiness based on the ESS with a score > 10 and trouble maintaining wakefulness (mean sleep latency < 10 minutes). Patients in Trial 5 were randomized to receive SUNOSI 150 mg or placebo by mouth for 12 weeks. This trial was used to primarily assess side effects.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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