Lower clinical success

Elderly In the two phase 3 clinical studies in patients with complicated skin and skin structure infections (cSSSI), lower clinical success rates were seen in patients 65 years of age and older compared with those younger than 65 years of age. In addition, treatment-emergent adverse events were more common in patients 65 years of age and older than in patients younger than 65 years of age in both cSSSI studies. 

When degenerative disc disease is the underlying cause of pain, conservative therapy may not alleviate the patient s symptoms. In the United States, fusion is the most common surgical procedure for chronic low back pain for patients who do not respond to conservative treatment [1]. In 2005, an estimated 228,000 Americans underwent lumbar spine fusion procedures for intractable lower back pain, and the annual number of lumbar fusions in the United States is projected to increase to 6.5 million by 2030 [3]. However, the clinical success rate of lumbar fusion is variable and reportedly ranges between 16 and 95% [4]. Furthermore, fusion of a painful degenerated disc has been associated with subsequent degeneration at adjacent intervertebral discs (sometimes referred to as adjacent segment disease by chnicians) [5, 6]. 

The main role of the human thyroid gland is production of thyroid hormones (iodinated amino acids), essential for adequate growth, development, and energy metaboHsm (1 6). Thyroid underfunction is an occurrence that can be treated successfully with thyroid preparations. In addition, the thyroid secretes calcitonin (also known as thyrocalcitonin), a polypeptide that lowers excessively high calcium blood levels. Thyroid hyperfunction, another important clinical entity, can be corrected by treatment with a variety of substances known as antithyroid dmgs. 

With an approved IND, the drug company can place me in humans at lower doses, mainly to observe any overt symptoms of toxicity and to evaluate my PK characteristics, and the study may use 10 to 20 healthy subjects. These data are then resubmitted to FDA (Phase 1). After my Phase I is completed, drug testing begins for my clinical efficacy, with trials at different doses and given to different populations under strict supervision. A successful study may require a few thousand patients and the involvement of several study centers across the country (or perhaps across the world) to collect extensive data. It is not unusual to have 100,000 patients take me before the data are submitted to the FDA for drug approval — the so-called marketing approval. 

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