New? Budesonide approved yesterday by FDA

[Zizzle]

How is this different than regular Entocort?

FDA Greenlights New Oral Steroid for Colitis
By Nancy Walsh, Staff Writer, MedPage Today
Published: January 15, 2013

An extended release formulation of budesonide (Uceris) for the treatment of mild-to-moderate ulcerative colitis received FDA approval today.

Budesonide is a corticosteroid, and the new prescription-only tablet formulation allows local administration throughout the colon using proprietary "multi-matrix" drug delivery technology, according to the manufacturer, Santarus.

This represents "an important new therapeutic option" for patients with this condition, commented William Sandborn, MD, of the University of California San Diego, in a press release.

He pointed out that the drug is "indicated for use in the induction of remission of active disease, an acute phase of the disease often characterized by cramping, bloating, diarrhea, bleeding, fatigue, weight loss, and frequent bowel movements."

The approved regimen in adults is a single 9-mg tablet each morning, with or without food, for up to 8 weeks.

Patients should be cautioned that a number of adverse effects are associated with the use of corticosteroids, including osteoporosis and glaucoma, adrenal suppression, and an increased risk of infection.

In particular, patients should be advised to avoid individuals with contagious diseases such as measles and chickenpox.

They also should not consume grapefruit or grapefruit juice while taking the medication because of the possibility of increased drug levels in the bloodstream.

Common side effects seen with this agent include nausea, gas, constipation, fatigue, and headache, the company noted.

The drug is expected to become available in March.

Santarus, based in San Diego, collaborated on the drug with Cosmo Pharmaceuticals of Lainate, Italy.

[wonderwoman]

One big difference is the 9mg is in one tablet rather than three capsules. Harder to reduce dosage if you find stool becoming too firm when it's in one tablet.

[tex]

Besides the concentrated form, it's also an extended release version. Now call me an ignorant old country boy, but as far as I can tell, corticosteroids provide the most benefits when used as a single dose that provides a "shock" effect to the system, and then the effect is allowed to slowly decay, over time, with steadily-decreasing doses (that's why prednisone in normally prescribed in a regimen that features a full dose up front, followed by a steadily-decreasing dosage rate). In that context, "extended release" is incongruent, so it remains to be seen whether this version will prove to be any more or less beneficial than the previously-existing formulations.

It sort of sounds as though someone is trying to "create" a market for a new product for which no existing need is apparent.

Tex

[ant]

How is this different than regular Entocort?

Does not sound different at all except that 9gm is in one, rather than three, tablets (so less flexible).

Is this just some legal wheeze round a patent or what? What drug company is making this?

Best, ant

[Leah]

I agree. How can you taper slowly from this.?.. and I thought Tex had said that Budesonide doesn't work well for UC?

Leah

[tex]

and I thought Tex had said that Budesonide doesn't work well for UC?

It would work better if it were delivered farther downstream, and that may be the case with this version, because it uses a new encapsulation/delivery mechanism.

The MMX® technology allows the delivery of active pharmaceutical ingredients into the lumen of the colon through tablets in a delayed and controlled extent with the effect that the active pharmaceutical ingredients can be applied to the full length of the colon.

Their site includes a video on how it works (if you can get the video player to work — I must have too many obstacles in my browser, because I couldn't get it to play).

http://www.cosmopharmaceuticals.com/act ... ology.aspx

This delivery technology may be the next big thing in the drug treatment of IBDs.

http://www.utsandiego.com/news/2013/jan ... -approval/

Tex

[Gloria]

Santarus said it will start selling Uceris in March. The specialty drug company is hiring 85 more salespeople, Gerald T. Proehl, president and CEO of Santarus, said in a conference call with analysts Tuesday.

The company expects to meet or beat its 2012 earnings guidance of about $210 million in revenue, and net income of about $12 million to $14 million, said Chief Financial Officer Debra Crawford.

It sounds like they're counting on it being a big money-maker, so we can't hope for a cheaper version. Plus, the coating is what gives the delayed reaction, so breaking it into smaller dosages won't work.

Gloria