FDA Approves New "Dry" Steroid Nasal Spray

On March 26, 2012, the FDA approved of a new type of steroid nasal spray in the treatment of nasal allergies that puffs powder into the nose rather than a liquid. Liquid formulations such as nasonex, flonase, veramyst, nasacort, and rhinocort has been until now the only delivery medium of administration.

This new spray made by Teva Pharmaceuticals is called QNASL which puffs a steroid beclomethasone dipropionate. For those who know pharmaceuticals, it is the same active ingredient as (liquid) beconase nasal spray.

Just like the other nasal sprays, administration is 2 puffs (sprays) in each nares daily.

This spray does pretty much the same thing (and has similar side effects) as the other established nasal sprays. However, QNASL may be better tolerated in those patients who HATE the drip down the back of the nose after liquid nasal spray use.

Drug should be available for prescription starting in April 2012.

Source:
Teva Announces FDA Approval of QNASLTM (beclomethasone dipropionate), a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis. Teva Pharma 3/26/12

FDA Approves New Surgical Reflux Treatment

On March 22, 2012, the FDA approved the LINX Reflux Management System to treat gastroesophageal reflux disease (GERD). Developed by Torax Medical, the

"LINX system is composed of a series of titanium beads, each with a magnetic core, connected together with independent titanium wires to form a ring shape like a bracelet of beads. It is implanted at the lower esophageal sphincter (LES), a circular band of muscle that closes the last few centimeters of the esophagus and prevents the backward flow of stomach contents. The force of the magnetic beads is designed to provide additional strength to keep a weak LES closed. Upon swallowing, the magnetic force between the beads is overcome by the higher pressures of swallowing forces, and the device expands to accommodate a normal swallow of food or liquid. Once the food passes though the LES, the device returns to its resting state."

Traditionally, surgical management of reflux entailed a stomach wrap called Nissen Fundoplication which is analogous to cinching a belt and is currently the gold standard. Trans-oral incisionless fundoplication is a newer approach to the Nissen fundoplication and is in essence an "internal" stomach wrap.

It is only a matter of time to see whether this new LINX system is as effective if not more effective than fundoplication over a long period of time or whether it will go the way of the Dodo bird.

An immediate disadvantage of this system... Patients can never undergo a MRI scan in the future (LINX uses magnetic beads... MRI which utilizes a strong magnet... Visualization of beads being yanked out of the human body in a MRI machine...)

Reference:
FDA approves LINX Reflux Management System to treat gastroesophageal reflux disease. FDA 3/22/12

U.S. Marshals Seize Auralgan Otic Solution (Unapproved FDA Medication)

Auralgan Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections, was being distributed in violation of federal law because the product does not have FDA approval and its labeling does not include adequate directions for use.

On Feb. 5, 2010, the FDA issued a Warning Letter to Deston, the maker of Auralgan, citing the company for distributing unapproved new drugs and misbranded drugs.

As such, on Feb 15, 2011, US Marshals seized all lots of Auralgan Otic Solution warehoused at Integrated Commercialization Solutions Inc. (ICS) in Brooks, KY.

Read the FDA notice here.