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In the pipeline
Drugs in Development and New Indications
Antibody Advancement
A new development at the University of Massachusetts Medical School (UMMS) has
opened the door to a promising treatment for lung cancer therapy. The novel monoclonal
antibody, DMF-10, catalyzes the process of apoptosis when it binds to tumor cells,
causing cancer cells to self-destruct while leaving normal, noncancerous cells
unharmed. Teamed up with Australia-based company EvoGenix, UMMS is dedicated
to further development of the antibody, and hopes to fast-track the treatment
for clinical trials.
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OTC Obesity Drug
The US Food and Drug Administration (FDA) has issued an approvable letter to
GlaxoSmithKline, Inc, for its plan to market a lower dose, over-the-counter (OTC)
version of the prescription diet drug orlistat (Xenical). Orlistat aids in weight-loss
by blocking fat absorption and is a prescription-quality alternative to unregulated
OTC diet aids. In January 2006, a federal advisory panel determined that the
drug could be sold without a prescription. If approved, orlistat will become
the first OTC weight loss drug to attain FDA clearance.
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Rest for the Weary
Recent data presented at the 58th Annual Meeting of the American Academy of Neurology
demonstrated that treatment with pramipexole significantly improved symptoms
of restless legs syndrome (RLS). These data are derived from multiple studies
involving almost 500 patients. Pramipexole is currently approved for idiopathic
Parkinson disease, and a supplemental new drug application has been filed with
the FDA to extend its use
to treat RLS. It is estimated that one in every 10 adults suffers from RLS.
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Extending the Cycle
Barr Pharmaceuticals, Inc, and subsidiary company Duramed Pharmaceuticals, Inc,
have announced that the FDA has determined no further clinical data are necessary
for the approval of its newest extended-cycle levonorgestrel (LNG)/ethinyl
estradiol (EE) oral contraceptive (Seasonique). The company plans to work with
the FDA to resolve questions regarding the labeling and postmarketing of the
product in order to expedite the approval. Like its predecessor already on
the market (Seasonale), the drug would offer users 84 days of combination therapy
(LNG .15 mg/EE .03 mg), followed by 7 days of unopposed estrogen (EE .01 mg).
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Synthetic Surfactant
for RDS
Discovery Laboratories, Inc, has announced that it has received a second approvable
letter from the FDA for its pulmonary surfactant (lucinactant [Surfaxin]).
Lucinactant is a synthetic surfactant that imitates the function of natural
human lung surfactants, and is used for the prevention of respiratory distress
syndrome in premature infants—a life-threatening breathing disorder affecting
tens of thousands of infants in the United States each year.
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