Trial 2

 

SOLOSEC

(N=107)* 

n (%)

 

Placebo

(N=57)* 

n (%)

 

* N=number of patients in treatment group (modified intent-to-treat population defined as all patients randomized who had a baseline Nugent score ≥4 and were negative for other sexually transmitted infections at baseline). † Patients missing one or more of the clinical assessments were considered as non-responders/not cured. ‡ Difference in response (SOLOSEC – placebo) and 95% confidence interval § Patients with missing Nugent scores were considered Nugent score failures.  

 

      Clinical Responder†

62 (57.9) 14 (24.6) 

 33.3 (17.4, 49.2)‡ 

p<0.001 

 

      Nugent Score Cure§

49 (45.8) 2 (3.5) 

 42.3 (30.4, 54.2)‡ 

p<0.001 

 

      Therapeutic Responder

37 (34.6) 2 (3.5) 

 31.1 (19.6, 42.6)‡ 

p<0.001 

 

16 HOW SUPPLIED / STORAGE AND HANDLING 

  

 

SOLOSEC (secnidazole) Oral Granules, 2 g, consists of off-white to slightly yellowish granules containing secnidazole. SOLOSEC is supplied in a unit-of-use package containing one packet of granules in an individual carton. Each packet contains 4.8 g of granules containing 2 g secnidazole. SOLOSEC is supplied as follows:

 

NDC 27437-051-01 carton containing one unit-of-use 2 g packet

 

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room temperature].

 

17 PATIENT COUNSELING INFORMATION 

 

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

 

Administration Instructions 

 

Instruct the patient:

To sprinkle the entire contents of the packet of SOLOSEC onto applesauce, yogurt or pudding and take all the mixture within 30 minutes without chewing or crunching the granules.

That after consuming the mixture, they may take a glass of water to aid in swallowing.

That SOLOSEC is not intended to be dissolved in any liquid.

 

Advise the patient that SOLOSEC may be taken without regard to the timing of meals.

 

Lactation 

 

Advise women not to breastfeed during treatment with SOLOSEC and to discontinue breastfeeding for 96 hours following the administration of SOLOSEC. Also, advise a nursing mother that she may choose to pump and discard her milk for 96 hours after administration of SOLOSEC and feed her infant stored human milk or formula [see Use in Specific Populations (8.2)]. 

 

Vulvo-Vaginal Candidiasis 

 

Advise the patient that use of SOLOSEC may result in vulvo-vaginal candidiasis that may require treatment with an antifungal agent.

 

Drug Resistance