SUBSYS (fentanyl sublingual spray) is a potent opioid analgesic intended for sublingual mucosal administration.

SUBSYS is formulated to be sprayed underneath the tongue to allow for absorption of fentanyl across the sublingual mucosa.

Active Ingredient: Fentanyl is N-phenyl-N-[1-(2-phenylethyl)-4piperidinyl]propanamide. Fentanyl is a highly lipophilic compound (octanolwater partition coefficient at pH 7.4 is 860:1) that is freely soluble in ethanol and methanol and practically insoluble in water (1:40). The molecular weight of the free base is 336.47. The pKa is 8.4. The compound has the following structural formula:

SUBSYS™ (fentanyl) Structural Formula Illustration

Inactive Ingredients: dehydrated alcohol 63.6%, purified water, propylene glycol, xylitol, and L-menthol.

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