Item 7.01 Regulation FD Disclosure.
1. An intravenous injection pharmaceutical dosage form comprising: (a) a liquid dispersion medium selected from the group consisting of water, an aqueous salt solution, safflower oil, ethanol, t-butanol, hexane and glycol; (b) particles of meloxicam or a salt thereof having an effective average particle size of less than 200 nm; and (c) polyvinylpyrrolidone and sodium deoxycholate as surface stabilizers adsorbed on the surface of the meloxicam particles, wherein: (i) the surface stabilizer are essentially free of intermolecular cross-linkages; (ii) meloxicam is present in an amount of from about 99.5% to about 0.001%, by weight, based on the total combined weight of the meloxicam and the surface stabilizers; and (iii) the surface stabilizers are present in an amount of from about 0.01% to about 99.5%, by weight, based on the total combined weight of the meloxicam and the surface stabilizers.
5. A method of making an intravenous injection pharmaceutical dosage form comprising contacting meloxicam particles with polyvinylpyrrolidone and sodium deoxycholate as surface stabilizers in the presence of a liquid dispersion medium selected from the group consisting of water, an aqueous salt solution, safflower oil, ethanol, t-butanol, hexane and glycol for a time and under conditions sufficient to provide the intravenous injection pharmaceutical dosage form comprising meloxicam particles having an effective average particle size of less than 200 nm, wherein: (i) the surface stabilizers are essentially free of intermolecular cross-linkages; (ii) meloxicam is present in an amount of from about 99.5% to about 0.001%, by weight, based on the total combined weight of the meloxicam and the surface stabilizers; and (iii) the surface stabilizers are present in an amount of from about 0.01% to about 99.5%, by weight, based on the total combined weight of the meloxicam and the surface stabilizers.
13. A method of treating a subject in need thereof comprising intravenously injecting to the subject an effective amount of a pharmaceutical dosage form comprising: (a) a liquid dispersion medium selected from the group consisting of water, an aqueous salt solution, safflower oil, ethanol, t-butanol, hexane and glycol; (b) particles of meloxicam or a salt thereof; and (c) polyvinylpyrrolidone and sodium deoxycholate as surface stabilizers, wherein: (i) the surface stabilizers are essentially free of intermolecular cross-linkages; (ii) the meloxicam particles have an effective average particle size of less than 200 nm; (iii) meloxicam is present in an amount of from about 99.5% to about 0.001, by weight, based on the total combined weight of the meloxicam and the surface stabilizers; and (iv) the surface stabilizer is present in an amount of from about 0.01% to about 99.5%, by weight, based on the total combined dry weight of meloxicam and the surface stabilizers.
1. An injectable pharmaceutical dosage form comprising: 30 mg of meloxicam, or a salt thereof, wherein the meloxicam is in the form of particles having an effective average particle size of less than or about 2000 nm; polyvinylpyrrolidone; sodium deoxycholate; sucrose; and water; wherein the dosage form does not comprise a combination of meloxicam and a vasomodulator.
6. An injectable pharmaceutical dosage form consisting essentially of: 30 mg of meloxicam, or a salt thereof, wherein the meloxicam is in the form of particles having an effective average particle size of less than about 400 nm; polyvinylpyrrolidone; sodium deoxycholate; sucrose; and water.
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Axsome's AXS-07 drug product candidate (20 mg MoSEIC™ meloxicam/10 mg
rizatriptan) is formulated into tablets for oral delivery. Axsome's New Drug
Application for AXS-07 for the acute treatment of migraine is currently under
review by the
The information in this Item 7.01 of this Current Report on Form 8-K shall not
be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of
1934, as amended, or otherwise subject to the liabilities of that section or
Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The
information contained in this Item 7.01 shall not be incorporated by reference
into any filing with the
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