5 results about "Cyclobenzaprine" patented technology

Methods for treating fibromyalgia and one or more of its associated symptoms of pain, sleep disturbance and / or fatigue comprising administering to a subject in need thereof, 5.6 mg cyclobenzaprine HCl per day in one or more dosage units by transmucosal administration, the cyclobenzaprine HCl being in a form of a eutectic, and the one or more dosage units further comprising a basifying agent.

The present disclosure provides methods for treating or managing fibromyalgia and its associated symptoms in a subject in need hereof characterized by an early onset of one or more of: (1) a reduction in widespread pain characterized by about 0.3 or more difference in the LS mean change in the NRS Pain Score; (2) a reduction in sleep disturbance characterized by about 2.9 or more difference in the LS Mean change in PROMIS Sleep Disturbance T-score; (3) a reduction in fatigue characterized by about 2.0 or more difference in the LS Mean change in PROMIS Fatigue T-score; or (4) an improved sleep quality characterized by about 0.5 or more difference in the LS Mean change in NRS Sleep Quality Score, each as compared to placebo, comprising administering to a subject in need thereof 2.8 mg or 5.6 mg cyclobenzaprine HCl once daily in one or more dosage units by transmucosal administration. The present disclosure also provides methods for preventing or avoiding one or more of a clinically meaningful change in mean weight, a clinically meaningful change in mean systolic blood pressure or mean diastolic blood pressure, or a decline in sexual functioning in conjunction with treating or managing fibromyalgia or its associated symptoms in a subject in need thereof, the treatment or management being characterized by the transmucosal administration of cyclobenzaprine HCl in one or more dosage units (e.g., a first dosage unit or a second dosage unit). The cyclobenzaprine HCl of these methods is in the form of a mannitol eutectic (e.g., a 75% ± 2% by weight cyclobenzaprine HCl and 25% ± 2% by weight β‑mannitol eutectic) and the one or more dosage units further comprise a basifying agent.

The present invention relates to pharmaceutical compositions and methods of manufacturing the same, comprising a eutectic of Cyclobenzaprine HCl and mannitol or Amitriptyline HCl and mannitol.

The invention provides compositions and methods for administering therapeutic compounds, particularly cyclobenzaprine or amitriptyline, for absorption through the mucosa, wherein the compositions contain a basifying agent in addition to the therapeutic agent. The compositions and methods have a number of unexpected pharmacokinetic benefits over oral administration. Methods of treating fibromyalgia in a human subject are also provided.