Efficacy

Social Anxiety Disorder (SAD)

SAD is underdiagnosed and risks leading to comorbid conditions

• Unfortunately, SAD is frequently not identified, and according to one study, 97% of patients go untreated within 1 year of onset[1]
• SAD precedes a comorbid psychiatric condition in up to 77% of cases[2][3]
  • LUVOX CR has not been proven in clinical trials to prevent or treat comorbid conditions
• SAD affects about the same number of people as major depressive disorder[4][5]

SAD patients are severely impaired in several aspects of daily functioning[6]

With early recognition and treatment, there is a way out...

Once-A-Day LUVOX CR provides statistically significant improvement vs placebo in SAD symptoms as measured by the LSAS at week 12[7][8]

• Statistical separation from placebo occurred as early as week 4

Results from a multicenter, randomized, double-blind, placebo-controlled study in an intent-to-treat population of 247 adult patients with generalized SAD who received Luvox CR or placebo once-a-day. Mean (SE) baseline LSAS Total Score was 90.1 (1.5) for the Luvox CR group, which is considered to be severe social phobia according to the LSAS. A 26.7 point mean change (30% reduction) from baseline resulted in an LSAS Total Score of 63.4 at study end, which is considered to be moderate social phobia according to the LSAS.[7][9][10]

• An identically designed 12-week, placebo-controlled study had similar results, with a mean dose at endpoint of 204 mg/day[11]

Once-A-Day Luvox CR (fluvoxamine maleate) Extended-Release Capsules are indicated for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD).

Obsessive Compulsive Disorder (OCD)

OCD is underdiagnosed and undertreated

• OCD patients are often reluctant to discuss their symptoms and delay seeking treatment an average of 7.5 years[12]
• OCD can be masked by major depressive disorder, which has a lifetime prevalence of 67% in OCD patients[13][14]
  • LUVOX CR is approved only for SAD and OCD[8]
• Some patients with OCD may require higher dosages than are needed in other disease states[15]
  • The approved dosage range for LUVOX CR is 100 mg/day to 300 mg/day[8]

OCD has a detrimental impact on many factors of quality of life

• Level of education[16]
• Employment status[6][16]
• Financial independence[16]

LUVOX CR has not been systematically studied for its impact on quality-of-life measures.

With early recognition and treatment, there is a way out...

Once-A-Day LUVOX CR provides statistically significant improvement vs placebo in OCD symptoms as measured by the Y-BOCS at week 12[8][17]

• Statistical separation from placebo occurred as early as week 2[17]

Results from a multicenter, randomized, double-blind, placebo-controlled study in an intent-to-treat population of 237 adult outpatients with OCD who received Luvox CR or placebo once-a-day. Mean (SE) baseline Y-BOCS Total Score was 26.6 (0.3) for the Luvox CR group, which is considered to be severe OCD according to Y-BOCS. An 8.5 point mean change (32% reduction) from baseline resulted in a Y-BOCS Total Score of 18.1 at study end, which is considered to be moderate OCD according to the Y-BOCS.[17][18]

Once-A-Day Luvox CR (fluvoxamine maleate) Extended-Release Capsules are indicated for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD).

Once-A-Day LUVOX CR^® (fluvoxamine maleate) Extended-Release Capsules are indicated for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD).

Important Safety Information

CONTRAINDICATIONS

The use of alosetron, tizanidine, thioridazine, or pimozide with LUVOX CR Capsules is contraindicated. The use of MAO inhibitors in combination with LUVOX CR Capsules, or within 14 days of discontinuing treatment with LUVOX CR Capsules, is contraindicated (see WARNINGS and PRECAUTIONS). LUVOX CR Capsules are also contraindicated in patients with a history of hypersensitivity to fluvoxamine maleate or any of its excipients.

ADVERSE EVENTS

In clinical trials, the most commonly observed adverse events with an incidence of ≥5% and at least twice that of placebo were nausea, somnolence, asthenia, diarrhea, anorexia, tremor, and sweating. Overall, these side effects were mild to moderate in severity and transient in nature. Other common adverse events (≥5% and at least twice that of placebo) included abnormal ejaculation and anorgasmia.

Please see full prescribing information, including boxed warning, for LUVOX CR.