Peak Bio-availability in 2-3 Minutes: Aegis Awarded 3rd Patent for Intravail(R)

Aegis Therapeutics LLC

Aegis’ Non-Invasive Drug Delivery System For Migraines (1)

Aegis Therapeutics LLC, the developers of drug delivery and drug formulation technologies has announced that it has received it’s 3rd patent for fast acting formulations of triptans, a widely used class of drugs including Sumatriptan, Zolmitriptan, Naratriptan, Rizatriptan, Eletriptan, Almotriptan and Frovatriptan. The total triptan class of drugs has a market of over $3 billion of which Sumatriptan alone accounts for $2 billion.

Trials on humans have demonstrated that the now patented Intravail® formulation of sumatriptan is bioavailable in 2-3 minutes of administration.  This is a 20-30 times faster achievement of therapeutic drug levels than what is currently marketed non-invasive/non-injectable sumatriptan products. (2)

The most common triptan formulations currently available commercially – the oral tablet and the nasal spray reach peak blood level concentration of the drug in 60-120 minutes – many times slower than Intravail® formulation of sumatriptan and thus delaying onset of pain relief.

The new technology – Intravail® formulation of sumatriptan is widely applicable to other small molecule as well as biotherapeutic drugs that step up

The enabling Aegis Intravail formulation technology is broadly applicable to a wide range of small molecule and biotherapeutic drugs to increase noninvasive bioavailability by the oral, nasal, buccal, and sublingual routes especially in those cases where speed is important to the patient. Acute symptoms and A&E cases with severe pain, nausea, emesis, convulsive disorders, spasticity is expected to be greatly helped by the new Intravail® formulation of sumatriptan by Aegis Therapeutic LLC.

SOURCE:

  1. Image credits: Aegis Therapeutics LLC; Web August 2013; http://aegisthera.com/
  2. Aegis Awarded 3rd Patent for Fast Acting Migraine Nasal Spray Treatment; Aegis Therapeutics LLC; Web August 2013; http://aegisthera.com/aegis-awarded-3rd-patent-for-fast-acting-migraine-nasal-spray-treatment/

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FDA Grants Approval To Rizatriptan Benzoate ODT For Acute Migraine Treatment

Migraine Blog Rizatriptan ODT

Rizatriptan Benzoate ODT approved by FDA and launched in the market.  Image is not of said drug (1)

Pharmaceutical company Breckenridge’s drug Rizatriptan Benzoate has been given the green flag for immediate launch by the U.S Food and Drug Administration. The drug comes in the form of orally disintegrating tablet (ODT). It is available commercially in packs of potency/dosage 5 mg and 10 mg.

Breckenridge’s drug Rizatriptan Benzoate ODT is manufactured and supplied by Natco Pharma Limited. Just like Merck & Co. Inc’s Maxalt MLT, Rizatriptan Benzoate ODT is a prescription drug used in the management and treatment of acute migraine.

The FDA granted final ‘go ahead’ for the Abbreviated New Drug Application (ANDA) for Rizatriptan Benzoate ODT some nine months prior to expiration of the pediatric-exclusivity period for the challenged Orange Book patent (April 1, 2014).

‘Breckenridge’s patent challenge regarding Rizatriptan Benzoate Orally Disintegrating Tablets is a continuing part of its larger aggressive Paragraph IV strategy commenced a few years ago. Since the beginning of 2011, Breckenridge has filed twelve (12) Paragraph IV patent challenges and intends to continue that trend in the next several years, focusing on niche Paragraph IV opportunities with certain barriers to entry.’ (2)

SOURCES:

  1. Image Credit: FreeDigitalPhotos.net; Yellow Tablet; Image by rakratchada torsap; Web July 2013; http://www.freedigitalphotos.net/images/agree-terms.php?id=10096441
  2. Breckenridge Pharmaceutical, Inc. Announces Approval of Rizatriptan Benzoate ODT (Orally Disintegrating Tablets): BioSpace.com; Web July 2013;  http://www.biospace.com/news_story.aspx?StoryID=301892&full=1

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New Rapid Relief Migraine Drug from MAPP Inc Issued U.S Patent

The US Patent and Trademark Office has issued MAP Pharmaceutical Inc’s new drug under the banner, “Method of Therapeutic Administration of DHE to Enable Rapid Relief of Migraine while Minimizing Side Effect Profile.”

Pulmonary Administration DHE from MAPP Issued Patent (1)

The drug’s primary ingredient DHE or Dihydroergotamine is MAPP’s proprietary formulation. The novelty of this new formulation is that it has proved to have rapid efficacy in curbing migraine pain but minimizes the adverse effects that other migraine formulations have.

To be able to achieve quick distribution, metabolization and excretion of the drug, the DHE drug involves pulmonary administration or inhalation of the drug. This is advantageous as the results are almost instantaneous because the drug does not undergo a ‘first-pass effect’ and is absorbed almost entirely into the general blood circulation through the lungs.

The drug has been named LEVADEX® is an orally inhaled investigational drug administered using the Company’s proprietary TEMPO® inhaler for the potential acute treatment of migraine in adults and targets the pharmacokinetic profiles described in this patent. DHE is a drug that is currently available in other dosage forms to treat migraine. (2)

SOURCES:

  1. Image from Ambro; Freedigitalphotos.net; February 2012; http://www.freedigitalphotos.net/images/view_photog.php?photogid=1499
  2. MAP Pharmaceuticals, Inc. (MAPP) Issued Additional U.S. Patent for Methods of Achieving Rapid Treatment of Migraine Based Upon Pharmacokinetic Profile; BioSpace; Febraury 2012; http://www.biospace.com/news_story.aspx?StoryID=250731&full=1

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