Axsome Therapeutics has been granted a patent for a method of treating migraines using a combination of meloxicam and rizatriptan. The patent describes orally administering a dosage form once daily to a human experiencing a migraine attack, with specific dosage amounts of meloxicam and rizatriptan. The dosage form includes a complex of meloxicam with a sulfobutylether-ß-cyclodextrin and a bicarbonate. This method aims to improve the bioavailability and pharmacokinetics of the NSAID for more effective pain relief. GlobalData’s report on Axsome Therapeutics gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on Axsome Therapeutics, Antibody-conjugate nanoparticles was a key innovation area identified from patents. Axsome Therapeutics's grant share as of September 2023 was 43%. Grant share is based on the ratio of number of grants to total number of patents.

The patent is granted for a method of treating migraine

Source: United States Patent and Trademark Office (USPTO). Credit: Axsome Therapeutics Inc

A recently granted patent (Publication Number: US11759522B2) describes a method for treating migraines using a specific combination of medications. The method involves orally administering a dosage form once daily to a human experiencing a migraine. The dosage form contains meloxicam and rizatriptan, along with a complex of meloxicam with a sulfobutylether-ß-cyclodextrin and a bicarbonate.

The dosage form is a solid oral dosage form, specifically a tablet, containing approximately 20 mg to 30 mg of meloxicam or a molar equivalent amount of a salt form of meloxicam, and approximately 8 mg to 13 mg of rizatriptan or a molar equivalent amount of a salt form of rizatriptan. Additionally, the dosage form includes about 75 mg to 150 mg of the sulfobutylether-ß-cyclodextrin and about 400 mg to 600 mg of the bicarbonate.

Upon orally administering the dosage form, the maximum concentration (Cmax) of meloxicam in the human being is reported to be from about 2,500 ng/mL to about 3,000 ng/mL or about 3×103 ng/mL. The area under the concentration-time curve (AUC0-inf) of meloxicam in the human being is reported to be from about 50,000 ng*hr/mL to about 70,000 ng*hr/mL or about 5×104 ng*hr/mL. The time to reach maximum concentration (Tmax) of meloxicam in the human being is reported to be less than 60 minutes or about 5×101 minutes. The mean elimination half-life of meloxicam is approximately 20 hours.

The bicarbonate used in the dosage form is specified as sodium bicarbonate. The patent claims also mention variations of the dosage form with sodium bicarbonate, where the Cmax, AUC0-inf, and Tmax values of meloxicam are similar to those mentioned above.

It is important to note that the method described in the patent is specifically for treating migraines in humans, particularly those experiencing acute pain. The dosage form, which is a tablet, contains specific amounts of meloxicam, rizatriptan, sulfobutylether-ß-cyclodextrin, and bicarbonate. The patent provides detailed information on the pharmacokinetic properties of meloxicam when administered in this specific dosage form.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies