Ms. Farley is a freelance medical writer based in Wakefield, Rhode Island.
Budesonide for Childhood Sleep Apnea
A recent study showed that a nasal
spray form of the corticosteroid budesonide
improves nighttime breathing for
children with mild sleep apnea. Previous
studies demonstrated that intranasal
corticosteroids reduce the size of the
nasal tissues in the upper airway. While
the treatment is usually reserved for children
with more severe obstructive sleep
apnea, this study sought to determine
effects on children with milder apnea.
The 62 study participants received
either a spray of budesonide or a spray
of placebo
in each nostril at bedtime for
6 weeks, at which time they switched
to the other treatment for 6 weeks.
Children who received the budesonide
sprays had significant improvements
to their quality of sleep, as well as significant
reductions
in the size of their
adenoids. Study authors are encouraged
by these results and hope that this data
supports "temporarily throwing away
the scalpel" for children with mild sleep
apnea. The report
appears in the July
2008 issue of Pediatrics.
Osteoporosis Drug Update
A recent news release announced that Amgen's osteoporosis drug denosumab
performed well in late-stage clinical trials. After testing the drug on 1400 men over
a 3-year period, researchers found that denosumab increased bone density in the
lumbar spine when compared with placebo. Men who were taking denosumab
also reported fewer fractures in the vertebrae than those in the placebo group.
In the company?s largest drug development venture to date, Amgen is testing the
drug in 19,000 patients who are being treated for bone cancer or cancer-related
bone loss.
Azilect Slows PD
Progression
Based on the results of the ADAGIO
study, Teva Pharmaceuticals plans to
submit results to regulatory authorities
in the United States and Europe, which
could lead to Azilect becoming the first
treatment for Parkinson?s disease (PD)
to have a label for disease modification.
The ADAGIO study was a 1176-patient,
randomized, multicenter, double-blind,
placebo-controlled study of rasagiline
and its ability to modify PD in untreated
patients. Study participants were
divided into 2 groups: (1) the earlystart
group that received 1 or 2 mg/
day of rasagiline for 72 weeks or (2)
the delayed-start group that received
36 weeks of placebo followed by 36
weeks of rasagiline 1 to 2 mg/day. Teva
announced at the 12th Congress of
European Federation of Neurological
Societies in August that Azilect slowed
the progression of PD with the 1-mg
dose and met all 3 primary end points,
as well as the secondary end point with
statistical significance.
Company Gears Up for 2 New Obesity Drugs
Orexigen Therapeutics is randomizing
patients for a phase 2b trial of
Empatic (a combination of zonisamide
and bupropion, both approved by the
FDA)—1 of 2 obesity drugs that they
have in the works. The trial will be
a randomized, double-blind, placebo-controlled
trial of 720 generally healthy,
nondiabetic obese patients at 20 US
sites. For the study, patients will be
placed in 6 treatment groups, which
include 2 of the Empatic doses associated
with weight loss in the previous
phase 2b trial. Researchers will compare
the drug with zonisamide monotherapy,
bupropion monotherapy, and placebo.
Orexigen expects results in mid- to
late-2009. Results from the company's
previous trial were highly encouraging
in terms of safety and efficacy. Those
study results included weight loss at
48 weeks ranging from 11% to 15%.
Discontinuation rates were not statistically
different from placebo. Orexigen's
other drug is Contrave, now in phase 3
trials. The company is anticipating great
potential in both drugs.
New Hope for Melanoma Treatment
A new drug combination of interferon
alfa-2b and lovastatin from NeoPlas
Innovation has stopped the progress or
eradicated the tumors in at least 80% of
melanoma patients.
Although testing is in early stages,
researchers point to the case of the first
person treated with NeoPlas' protocol.
Diagnosed with stage 4 melanoma and
a life expectancy of only 8 weeks, this
patient was treated with the NeoPlas
drug combination and had a complete
response, remaining disease-free for 8
years. While complete eradication of
tumors or long-term stability is most
common with this treatment, many
patients will at least see their disease
progression slow substantially.
According to research, the drugs
included in the combination are not
effective when administered alone, but
when given as part of a combination
therapy, the dosages are lower, more
tolerable, and much more effective. The
unique combination works by disabling
specific abnormal cellular processes that
are typical of aggressive malignancies.
Researchers are hopeful that this combination
can be effective not only for
melanoma but pancreatic cancer, colon
cancer, renal cancer, mesothelioma,
osteosarcoma, chondrosarcoma, and
malignant fibrous histiocytoma.
Inside the Issue
