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Genzyme announced the FDA approval of Lumizyme (alglucosidase alfa), a lysosomal glycogen-specific enzyme, for the treatment of patients ≥8 years of age with late (non-infantile) onset Pompe disease (acid α-glucosidase (GAA) deficiency) who do not have evidence of cardiac hypertrophy.

The FDA has revised its recommendations on the suspension of rotavirus vaccine use and has determined that it is appropriate for healthcare providers to resume the use of Rotarix (live, attenuated human G1P[8] rotavirus vaccine, from GlaxoSmithKline) and RotaTeq (pentavalent, live rotavirus vaccine, from Merck).

Low back pain is one of the top 10 most common reasons for doctor office visits in the United States; approximately 80% of adults seek care at some time for acute low back pain. The differential diagnosis for low back pain and the importance of identifying clinical red and yellow flags during evaluation was presented at the 29th Annual Scientific Meeting of the American Pain Society.

Pretreatment with indomethacin associated with phosphatidylcholine (INDO-PC) has both analgesic and anti-inflammatory effects without the gastrointestinal toxicity usually observed with the NSAID indomethacin, according to results of a postsurgical incision pain model that was presented at the American Pain Society’s 29th Annual Scientific Meeting.

There is growing evidence that the way individuals cope with and appraise disease-related pain (e.g. arthritis pain and cancer) is not only related to their experience of pain but also to their physical and psychological functioning. Presenting at the American Pain Society 29th Annual Scientific Meeting, Francis J. Keefe, PhD, from Duke University Medical Center in Durham, N.C., reviewed the latest research in behavioral and psychosocial factors in pain and pain management.

Does prior use of opioids for migraine headaches reduce responsiveness to subsequent acute migraine therapies, as limited evidence has suggested? Results of a post-hoc analysis of data from a randomized, double-blind, placebo-controlled trial suggest the answer is “no,” specifically regarding efficacy of telcagepant, a novel investigational oral calcitonin gene-related peptide receptor antagonist that has acute antimigraine efficacy comparable to oral triptans.
This was reported during the American Pain Society’s 29th Annual Scientific Meeting.

The FDA has approved Crestor (rosuvastatin calcium tablets, from AstraZeneca) to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD).

The FDA has approved Cervarix (human papillomavirus bivalent [types 16 and 18] vaccine, recombinant, from GlaxoSmithKline) for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and women 10-25 years of age.

The FDA has warned four companies that they must stop marketing unapproved codeine sulfate tablets, an opioid analgesic indicated for the treatment of pain.

Orexigen Therapeutics announced positive results from its Phase 2b trial for Empatic (bupropion SR/zonisamide SR), its investigational combination drug for the treatment of obesity.