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MarketScreener Homepage  >  Equities  >  Nasdaq  >  Axsome Therapeutics Inc    AXSM

AXSOME THERAPEUTICS INC

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Patent Application Titled “Pharmaceutical Compositions Comprising Meloxicam” Published Online (USPTO 20190224321): Axsome Therapeutics Inc.

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08/14/2019 | 05:08pm EDT

2019 AUG 14 (NewsRx) -- By a News Reporter-Staff News Editor at Biotech Business Daily -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a patent application by the inventor Tabuteau, Herriot (New York, NY), filed on April 2, 2019, was made available online on July 25, 2019.

The assignee for this patent application is Axsome Therapeutics Inc. (New York, New York, United States).

Reporters obtained the following quote from the background information supplied by the inventors: “Meloxicam, which has the structure:

“##STR00001##

“is a nonsteroidal anti-inflammatory (NSAID) drug that exhibits anti-inflammatory, analgesic, and antipyretic activities. The meloxicam mechanism of action may be related to prostaglandin synthetase (cyclo-oxygenase, COX) inhibition which is involved in the initial steps of the arachidonic acid cascade, resulting in the reduced formation of prostaglandins, thromboxanes and prostacylin.”

In addition to obtaining background information on this patent application, NewsRx editors also obtained the inventor’s summary information for this patent application: “Meloxicam and some other NSAIDs have poor aqueous solubility which may reduce bioavailability and slow the onset of pain relief resulting from their use. One means of increasing the solubility and bioavailability of meloxicam is through the use of cyclodextrins. Cyclodextrin (also known as cycloamyloses) are generally cyclic polysaccharides which form a bucket-like shape. Cyclodextrins help to increase bioavailability of other molecules because cyclodextrins are hydrophobic on the inside and hydrophilic on the inside which helps to facilitate the transport of molecules. The naturally occurring cyclodextrins include six, seven, and eight glucose units (.alpha., .beta., and .gamma.-cyclodextrin, respectively). However, synthetic cyclodextrins containing more or less glucose units are possible. In aqueous solutions, cyclodextrins can form complexes (i.e., an inclusion complex) with drugs by incorporating the drug into the center/hydrophobic portion of the cyclodextrin ring; although cyclodextrin compounds are also known to aggregate around a drug in a micelle-type structure. This ability of cyclodextrins may allow them to act as carriers to increase the bioavailability of less soluble drugs.

“Some embodiments include an inclusion complex of meloxicam in a cyclodextrin.

“Some embodiments include a dosage form comprising: 1) an inclusion complex of meloxicam and a cyclodextrin, or 2) meloxicam and a carbonate or a bicarbonate.

“Some embodiments include a method of administering meloxicam orally, comprising orally administering a dosage form described herein to a patient in need of treatment.

“Some embodiments include a method of administering meloxicam intravenously, comprising intravenously administering a dosage form described herein to a patient in need of treatment.

“Disclosed herein are formulations for an inclusion complex of cyclodextrin and meloxicam with bicarbonate and methods of use thereof.

“Disclosed herein are formulations and methods for delivering meloxicam with cyclodextrin to a subject by oral, enteral, intravenous, intramuscular, subcutaneous, intranasal, or other parenteral means.

“Disclosed also are methods for treating pain and pain associated with conditions by delivering a dosage form with meloxicam, cyclodextrin, and bicarbonate by oral, enteral, intravenous, intramuscular, subcutaneous, intranasal, or other parenteral means to a subject.”

The claims supplied by the inventors are:

“1. A method of improving oral bioavailability of meloxicam in a human being, comprising orally administering a solid dosage form comprising both a bicarbonate and meloxicam to the human being, wherein the solid dosage form contains 400 mg to 900 mg of the bicarbonate, wherein the oral bioavailability of meloxicam for the solid dosage form in the human being is improved as compared with a first reference dosage form that: 1) contains the same amount of meloxicam; 2) does not contain the bicarbonate; and 3) does not contain a carbonate, or a second reference dosage form that: a) contains the same amount of meloxicam; b) does not contain the bicarbonate; and c) contains an amount of potassium carbonate that achieves about the same pH as the bicarbonate; wherein the solid dosage form has been shown to have a median C.sub.max that is about 1800 ng/mL to about 3000 ng/mL in fasted human subjects.

“2. The method of claim 1, wherein the solid dosage form further comprises a cyclodextrin.

“3. The method of claim 2, wherein the cyclodextrin is a sulfobutyl ether .beta.-cyclodextrin (SBE.beta.CD).

“4. The method of claim 2, wherein the solid dosage form further comprises an acid inhibitor.

“5. The method of claim 4, wherein the acid inhibitor is esomeprazole.

“6. The method of claim 1, wherein the solid dosage form is in a tablet form.

“7. The method of claim 1, wherein the solid dosage form comprises about 1 mg to about 50 mg of meloxicam.

“8. The method of claim 7, wherein the solid dosage form comprises about 15 mg of meloxicam.

“9. The method of claim 1, wherein the bicarbonate is sodium bicarbonate or potassium bicarbonate.

“10. The method of claim 9, wherein the solid dosage form comprises 400 mg to 600 mg of sodium bicarbonate.

“11. The method of claim 10, wherein the solid dosage form comprises 500 mg of sodium bicarbonate.

“12. The method of claim 5, wherein about 30 mg to about 50 mg of esomeprazole is present in the solid dosage form.

“13. The method of claim 1, wherein the oral bioavailability of meloxicam in the solid dosage form is improved at least by about 10%.

“14. The method of claim 2, wherein the oral bioavailability of meloxicam in the solid dosage form is improved at least by about 30%.

“15. The method of claim 1, wherein the oral bioavailability of meloxicam in the solid dosage form is improved at least by about 50%.

“16. The method of claim 1, wherein the oral bioavailability of meloxicam in the solid dosage form is improved by about 100%.

“17. The method of claim 2, wherein the oral bioavailability of meloxicam in the solid dosage form is improved by about 200%.

“18. The method of claim 1, wherein the solid dosage form has been shown to have a median C.sub.max of meloxicam that is about 2000 ng/mL to about 2500 ng/mL in fasted human subjects.

“19. The method of claim 1, wherein the solid dosage form has been shown to have a median C.sub.max of meloxicam that is about 2200 ng/mL to about 2400 ng/mL in fasted human subjects.

“20. The method of claim 1, wherein the solid dosage form is orally administered to the human being to treat pain.

“21. The method of claim 20, wherein the pain is inflammatory pain.

“22. The method of claim 1, wherein the solid dosage form is orally administered to the human being to treat osteoarthritis, rheumatoid arthritis, or juvenile rheumatoid arthritis.”

For more information, see this patent application: Tabuteau, Herriot. Pharmaceutical Compositions Comprising Meloxicam. Filed April 2, 2019 and posted July 25, 2019. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220190224321%22.PGNR.&OS=DN/20190224321&RS=DN/20190224321

(Our reports deliver fact-based news of research and discoveries from around the world.)

Copyright © 2019 NewsRx LLC, Biotech Business Daily, source Health Newsletters

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Financials (USD)
Sales 2019 -
EBIT 2019 -49,4 M
Net income 2019 -50,6 M
Finance 2019 9,36 M
Yield 2019 -
P/E ratio 2019 -16,8x
P/E ratio 2020 -19,2x
EV / Sales2019 infx
EV / Sales2020 77,0x
Capitalization 848 M
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Number of Analysts 6
Average target price 36,83  $
Last Close Price 24,63  $
Spread / Highest target 103%
Spread / Average Target 49,5%
Spread / Lowest Target 1,50%
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NameTitle
Herriott Tabuteau Chairman & Chief Executive Officer
Mark L. Jacobson Secretary & Vice President-Operations
Nick Pizzie Chief Financial Officer
Cedric O'Gorman SVP-Clinical Development & Medical Affairs
Roger A. Jeffs Lead Independent Director
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