Forest Laboratories (NYSE: FRX) is introducing a new, twice a day, DPI format anticholinergic drug. Named aclidinium bromide, (Genuair, Eklira – trade name) this medication is purported to have a sustained effect for up to 24 hours. It may be offered in three strengths.
According to the manufacturer, it is faster arriving at the target M3 site than tiotropium and so, therefore, is supposed to have fewer side effects because it does not remain in solution in the plasma for as long a period of time. The inhaler mechanism itself is quite advanced, displaying a warning when ten doses remain, has a faint taste to confirm dosing and also has a visual color change when the dispenser detects enough flow that adequate dosage has been achieved.
In 2010, the FDA received their application to test this drug with formoterol fumarate.
Daliresp (rolfumilast) is a new medication also made by Forest Laboratories. Released in the spring of 2011, the therapeutic action of the drug is not well understood. It increases c-AMP, but is not a bronchodilator. According to the company press release, “It is the first and only selective phosphodiesterase-4 (PDE4) inhibitor approved by the FDA.” The once daily tablet is offered at 500mcq and is now widely availiable. Daliresp claims to have decreased “moderate and severe exacerbations by 15-18% in clinical trials.”
Be advised. 5.9% of patients taking the drug during clinical trials had “adverse psychiatric reactions” compared to 3.3% treated with placebo. Three suicide attempts were attempted during the trials and one of these was completed. These three attempts occurred inside a test population of 3100 participants. Weight loss is common, up to 10% of pre trial weight. This drug significantly boosts liver P450. Use with liver impairment is not recommended. 10% of trial participants had diarrhea vs 3% of placebo users.
Novartis announced that the FDA has approved their new, once daily, DPI format, long acting broncholdilator named indacaterol maleate. (Arcarpta) The company professes that the drug has a measurable effect on lung function within five minutes and is only for stable COPD. Based on the product literature that is to be offered, Arcapta is “not indicated for asthma.” It has not been studied “in patients with acutely deteriorating COPD. Use in this setting is inappropriate.”
Further, the corporation has plans for release of a new drug which they claim will produce revenues of “4 billion USD” currently named QVA149. The combination preparation is a mixture of indacaterol (above mentioned) and glycopyrronium bromide. This is a LABA/LAMA combo like Combivent or Duodose, but with much longer effects. The implication for tomorrow’s combination drug would be Spiriva together with Serevent or Foradil.
Dulera, made by Merck, is a combination preparation of two drugs – a long acting bronchodilator named formoterol fumarate, ( the active ingredient in Foradil) and a steroid mometasone furoate, (the active ingredient in Asmanex) Meant to compete with Advair and Symbicort, Merck released this drug summer 2010. These drugs are well studied and are just being packaged for ease of use and for marketing purposes.
The Reece cup approach to medications, “Hey, you got chocolate in my peanut butter. No, you got peanut butter in my chocolate” is a rapidly growing mode for comprehensive treatment. These multitargeting agents reduce the symptoms of lung disease, the way that simultaneously getting a cat, using mousetraps and baiting with De-Con all work together to reduce a rodent population. Expect combinations of LABAS LAMAS with various strengths of steroids within two to three years and attempts to put leukotriene inhibitors in after that.
Though these might be cheaper purchased as stand alones, their combined convenience outweighs the number one reason medications do not work: patient noncompliance with the drug regime. One giant breath, once a day, is the ultimate goal for achieving a stable, daily, therapeutic level. Absolute key to symptom control is marriage of this routine to another.
Therefore, LUNGLORD recommends all such drug combos should be kept on the shelf by the toilet, since this location is the most urgent and predictable of all A.M. routines. Such multitasking drug combos as part of natural life rhythms will produce the best outcomes.