In the clinical studies, theThe effect of STRIANT on patients’ teeth was not studied in clinical studies, but there is no data indicating there is an issue with STRIANT causing harm to patients’ teeth. No cases of ulceration, leukoplakia, or new oral lesions have been observed. In a multicenter, 12-week, open-label, single-arm, clinical trial (Study 1), gingivitis was common at baseline (32.6%), and was reduced at Week 4 (10.2%), Week 8 (10.2%), and Week 12 (11.2%). Similar findings were seen for gum edema.

In the US pivotal trial (Study 1) involving 98 patients, the most frequent adverse events that occurred with an incidence of 1% or greater which were possibly, probably, or definitely related to the use of STRIANT were: gum or mouth irritation (9.2%), gum pain (3.1%), gum tenderness (3.1%), and gum edema (2.0%). Also in Study 1, a total of 16 patients reported 19 gum-related adverse events. Of these, ten patients (10.2%), reported 12 events of mild intensity, four patients (4.1%) reported 5 events of moderate intensity and two patients (2.0%) reported 2 events of severe intensity.

Patients should be advised to regularly examine their gums in the area where they apply STRIANT. Any abnormal finding should be brought to the attention of their physician. They should also rotate STRIANT to alternate sides of their mouth with each application.

Transference is not an issue with STRIANT. STRIANT is delivered through the buccal mucosa, allowing for controlled and sustained absorption of testosterone through the gum and cheek surfaces that are in contact with the buccal system. Since venous drainage from the mouth is to the superior vena cava, trans-buccal delivery of testosterone circumvents first-pass hepatic metabolism. Testosterone that may be present in the saliva and swallowed is not expected to result in clinically significant serum testosterone concentrations due to extensive first-pass hepatic metabolism.

Patients should be reminded to discuss their STRIANT therapy with their oral health care professionals at their regularly scheduled dental appointment.

Yes, in most cases. But patients may need to make adjustments to the application process. Patients should call our toll-free patient support line at 1-866-STRIANT (787-4268) to speak with our medical staff about the steps that may be required in applying Striant while wearing dentures.

The product labeling notes that STRIANT, as with all testosterone therapy, may interact with the following drugs:

• Oxyphenbutazone: Concurrent administration of the nonsteroidal anti-inflammatory drug oxyphenbutazone with androgens may result in elevated serum levels of oxyphenbutazone
  
  
• Insulin: In diabetic patients, the metabolic effects of androgens may decrease blood glucose and therefore, insulin requirements
  
  
• Corticosteroids: Concurrent administration of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may enhance edema formation and should be administered cautiously, particularly in patients with cardiac or hepatic disease

In Study 1 (the pivotal trial), 4.1% of men reported bitter taste, and 2% reported taste perversion.

STRIANT delivers testosterone for the entire 12-hour dosing period. Removal of the used buccal system and replacement with a new buccal system maintains the continuous delivery of testosterone.

In Study 1 (the pivotal study), patient groups were defined according to whether or not the patient had received concomitant medications potentially causing dry mouth. Based on this evaluation, there was no significant effect on testosterone levels. [Study –05, pgs. 78, 79] There is no information on patients with medical conditions that cause dry mouth.

Patients with gum abnormalities were evaluated and there was no clinically significant effect on testosterone levels compared with patients with healthy gums. [Study –05, p. 81] For more information about the relationship between STRIANT and gums/teeth, please see Question #1.

Similar to other testosterone products, patients should be periodically checked for hemoglobin and hematocrit levels, liver function, prostate-specific antigen, cholesterol, and high-density lipoprotein. Serum concentrations of testosterone reach steady-state levels after the second dose of twice-daily STRIANT dosing. As with all testosterone therapies, serum testosterone concentrations may be checked four to twelve weeks after initiating treatment with STRIANT.

After the initial learning curve, the incidence of STRIANT falling off drops significantly. There are clear directions in the prescribing information about replacing STRIANT should it fall off. If STRIANT does not stick or falls off within the first 8 hours, patients should remove the original system and apply a new one. This counts as replacing the first dose. Apply the next system about 12 hours after the original buccal system was applied. If STRIANT falls off after 8 hours but before 12 hours, patients should replace the original buccal system. This replacement can serve as the second dose for that day.

Oral ingestion of STRIANT is not expected to result in clinically significant serum concentrations due to extensive first-pass hepatic metabolism. If swallowed, STRIANT should be replaced according to the directions in Question #11. STRIANT is not intended to be chewed or swallowed.

No specific food-effect study was conducted. However, patients in the studies were allowed to do these activities, and absorption of STRIANT was not significantly affected, indicating that they did not affect the use of STRIANT. Also, in Study 1 (the pivotal study) the effects of food and beverage consumption on serum testosterone concentrations were evaluated and no effect was found.

As a precaution, patients should always check to see if STRIANT is in place following toothbrushing, use of mouthwash, and consumption of food or alcoholic/nonalcoholic beverages. If STRIANT does not stick or falls off, the buccal system should be replaced according to the directions in Question #11.

No, STRIANT generally does not completely dissolve. As it absorbs moisture from the mouth, it will begin to soften and will mold to the shape of the gum. If there is any residue left at the end of the dosing period, it may be removed as described in the patient leaflet and the prescribing information.

Diabetics successfully participated in the clinical trials. However, their data were not analyzed separately. As with other testosterone replacement therapy, the metabolic effect of androgen may decrease blood glucose and therefore a diabetic patient’s insulin dose may need to be adjusted.

STRIANT is designed to be used and stay in place while patients are sleeping. It is necessary that patients keep STRIANT in place overnight to get the testosterone they need.

If a patient misses a dose, he should begin again with his next scheduled dose. Patients should be informed not to try to make up for a missed dose.

Study 1 has been submitted for publication. Study 2, an open-label, parallel, one-week, multicenter study comparing STRIANT with a transdermal system in 66 hypogonadal men has been accepted for publication by the Journal of Clinical Endocrinology and Metabolism.

Physicians must first ascertain that patients are using the buccal system properly. To capture the maximum serum concentration in patients, an early morning sample (just prior to applying the morning dose) is recommended. With STRIANT, no titration is necessary because one buccal system twice daily will work for most patients (86.6%). STRIANT is not indicated for more than one buccal system twice daily.

Based on the way managed care systems are currently structured, the cost of STRIANT will be reimbursed in most cases.

No. For some patients, the placement of STRIANT above the incisor tooth is much like wearing a contact lens: at first it may be noticeable, but after wearing the buccal system for a couple of days, patients won’t even know it’s there. Physicians can try the placebos to feel for themselves how comfortable STRIANT is.