Prepare your patients to stop seizures in their tracks

VALTOCO is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 years of age and older.1

Prepare your patients to stop seizures in their tracks

VALTOCO is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 years of age and older.1

VALTOCO offers rapid, reliable, ready seizure treatment

A 12-month, open-label, repeat-dose safety study of patients 6+ years of age found*:

Rapid: 4 minutes

4-minute median time from VALTOCO administration to seizure cessation2,*,†

  • 2-minute median time to seizure cessation when VALTOCO was administered within the first 5 minutes3
Sprayer icon with 2 minutes

Median time to VALTOCO administration2

2-minute median time to administer VALTOCO from seizure onset (range, -1-750 minutes)

4 minutes icon

Median time to seizure cessation after receiving VALTOCO2

4-minute median time to seizure cessation after VALTOCO administration (range, -1-1151 minutes)

When VALTOCO was administered early, within the first 5 minutes of seizure onset, the median time to seizure cessation was 2 minutes3

2-minute median time to seizure cessation graphic

*In patients experiencing episodes of frequent seizures despite daily antiseizure medication treatment.4
2-minute median time to seizure cessation following VALTOCO administration (range, 0-1440 min).3
1-minute median time to VALTOCO administration (range, 0-4 min).3

Reliable: 1 Dose

87% of seizure episodes used a single dose of VALTOCO over a 24-hour period4,*

  • 89% of seizure episodes in patients aged 6 to 17 years5

Patients with Epilepsy

Percentage of seizure episodes for which a single dose of VALTOCO was used over the course of 24 hours (N=3,853)4

Percentage of seizure episodes for which a single dose of VALTOCO was used over the course of 24 hours (N=3,853)

Proportion of patients using single or second doses

  • 52% of patients (n=84) never used a second dose over a 12-month period6
  • 48% of patients (n=79) received a second dose within the 24-hour period after the initial dose6
  • 8 patients accounted for 46% (224/485) of second doses administered7
Ready: 1 Hour

A majority of patients returned to their usual selves within 1 hour of administration of VALTOCO8,‡

  • Treatment-related somnolence was reported in 1.8% of patients4

The number of seizure-free days between treated seizure clusters doubled over a 12-month period in patients using VALTOCO9,§

Time to return to usual self for patients after the most recent administration of VALTOCO (N=64)8

Time to return to usual self for patients after the most recent administration of VALTOCO (N=64)

Overall mean sedation levels were low, mild, transient, and not considered clinically relevant10

Overall mean sedation levels were low, mild, transient, and not considered clinically relevant

Patients with Epilepsy

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The number of days between treated episodes of frequent seizures nearly doubled in patients using VALTOCO over a 12-month period9

SEIVAL increased by 12.9 days over a 12-month period (n=76)9

SEIVAL increased by 12.9 days over a 12-month period (n=76)

Patients with Epilepsy

SEIVAL increased independent of concomitant medication change 9

SEIVAL increased independent of concomitant medication change

*This was an exploratory analysis of a 12-month, open-label, repeat-dose safety study in patients 6+ years of age; the study did not have prespecified efficacy endpoints.4
Median time to seizure cessation of 4 minutes (range, -1-1151 minutes).2
59% of patients returned to their usual selves within 60 minutes of administration of VALTOCO as recorded in patient and caregiver surveys.8
§SEIVAL was measured as the time between VALTOCO doses using seizure diary data from the open-label safety study. Seventy-six of the 163 patients (47%) who received  ≥1 dose of VALTOCO in the study had  ≥1 SEIVAL in each of Periods 1, 2, 3, and 4 and were included in the consistent cohort for Periods 1-4. Retreatments, defined as second doses given within 24 hours of the first doses, were eliminated from the analysis.9

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This study represents one of the largest studies to date of treated episodes of frequent seizures11

VALTOCO sprayer
VALTOCO sprayer

Only VALTOCO uses Intravail® technology for rapid and reliable absorption of diazepam12,13

VALTOCO was formulated to address the principal limitations of intranasal drug delivery. Intravail® technology facilitates increased drug absorption across the nasal mucosa by increasing permeability of cell membranes and temporarily loosening tight junctions between cells, allowing the drug to pass through.14

Nearly complete absorption of VALTOCO with 97% bioavailability relative to intravenous diazepam1,12,||

Therapeutic plasma levels of VALTOCO sustained for 24 hours 1,12

Graph of therapeutic plasma levels of VALTOCO sustained for 24 hours

Reduction in seizure activity can occur at a diazepam concentration as low as 30 ± 15 ng/mL15,16

Predictable pharmacokinetics with low interpatient and intrapatient variability1,13,17,||

VALTOCO demonstrated 2- to 4-fold less pharmacokinetic variability than Diastat® (diazepam rectal gel) regardless of patient weight1,13,17

Pharmacokinetic variability profiles of VALTOCO and Diastat17

AUC, area under the curve; Cmax, maximum serum concentration.

90% CI

Graph of pharmacokinetic variability profiles of VALTOCO and Diastat
  • VALTOCO pharmacokinetics were not notably altered when administered during seizures vs under normal conditions10

||In adults.

See how VALTOCO works to optimize diazepam nasal delivery

Learn how the unique formulation of VALTOCO optimizes diazepam for nasal delivery, and how it helps patients manage episodes of frequent seizure activity whenever, wherever.

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VALTOCO was deemed clinically superior in administration to Diastat®

(diazepam rectal gel) by the US Food and Drug Administration (FDA) for patients 6+ years of age18

The intranasal route of administration of VALTOCO provides a major contribution to patient care over the rectal
route of administration by providing a significantly improved ease of use.18

Because of this, the FDA has determined that VALTOCO deserves orphan drug exclusivity.18

VALTOCO was strongly preferred in a patient survey8,#

#Data collected from patient diaries and patient and care partner surveys of patients 6+ years of age.8

90%

90% said it was “extremely easy” or “very easy” to train others to administer VALTOCO

87%

87% felt more comfortable being treated in public with VALTOCO than with diazepam rectal gel

84%

84% said they would prefer using VALTOCO as their seizure rescue exclusively in the future

79%

79% were very comfortable doing activities outside the home with VALTOCO available

Improvements in seizure worry and social functioning19

PATIENTS 18+ YEARS OF AGE WITH EPILEPSY

Graph of patients with reductions in seizure worry and improvements in social functioning

Mean total QOLIE-31-P scores increased from day 0 (n=71) to day 365 (n=53) by 5.2 points (from 57.3 to 62.5), which also exceeded the MIC threshold of 5.19.
MIC, minimally important change; QOLIE-31-P, Quality of Life in Epilepsy—Problems.

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Proven safety and tolerability with low rates of somnolence in patients 6+ years of age4

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A VALTOCO clinical study4

Primary objective

Assess the safety and tolerability of repeat doses of VALTOCO as intermittent chronic therapy to treat episodes of frequent seizures

Study design

Phase 3, 12-month, open-label, repeat-dose

Subjects

Patients with epilepsy, 6 to 65 years of age (N=163)

Interventions and outcome measures