Medication Assisted Treatments for Opioid-Use Disorder

In this post, I share a few thoughts about the benefits and limitations of medication-assisted treatment (MAT) for the moderate to severe opioid-use disorder (OUD). Background Approximately 2.1 million people suffer from OUD, a chronic relapsing illness characterized by repeated, compulsive opioid seeking or use despite harm. The most recent data on fatalities from the opioid overdose…

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Erythropoietic Protoporphyria: An Unmet Medical Need for a Severe Photodermatosis

In this post, I share a few thoughts about erythropoietic protoporphyria (EPP), a serious debilitating condition for which there are presently no approved treatments. EPP is a rare inherited disorder of heme biosynthesis characterized by dermal photosensitivity secondary to a partial deficiency of ferrochelatase. In a phenotypically similar X-linked protoporphyria (XLP), there is overactivity of the…

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Are Fentanyl Test Strips an Effective Strategic Intervention?

In this post, I share a few thoughts about the use of fentanyl test strips (FTS) to reduce opioid overdose complications and death. More than 2.1 million Americans have an opioid use disorder (OUD), including 626,000 with heroin related OUD. According data on the opioid overdose crisis from the January 4, 2019 issue MMWR, 47,600 Americans died of opioid overdoses in 2017, a…

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What Do Increased Overdose Deaths Tell Us About the Opioid Overdose Crisis?

In this post, I share a few thoughts about the most recent data on the opioid overdose crisis from Morbidity and Mortality Weekly Report (January 4, 2019) which show a 12% year over year increase in opioid overdose deaths (2016-2017). The opioid overdose crisis continues to worsen and evolve due to the ongoing increase in fatalities involving…

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Microbiome Modulation: The Next Frontier in Clinical Therapeutics

In August 2017, the NIH hosted a workshop to mark the 10th and final year of the Human Microbiome Project (HMP), a two-phase program that greatly increased our understanding of the role of human microbiota in human health and disease. Although this NIH initiative is over, it has spurred continued funding for human microbiome research from the NIH, other…

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Why Treatment Advances in Fibromyalgia Have Been Slow

Fibromyalgia is a common medical condition characterized by chronic widespread muscle pain, fatigue, and sleep disturbance affecting two to three percent of the total population. It is five to ten times more common in women than men, increases with age and can also be worsened by many factors, including physical trauma and emotional stress. In…

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505(b)(2) New Drug Applications: Is there an adequate ROI?

In this post, intended for a general audience, I share a few thoughts about the benefits and limitations of developing drugs using the 505(b)(2) regulatory pathway. Hardly a week goes by without a pharmaceutical company expressing the desire to reap the benefits of developing a drug using the “505(b)(2) regulatory pathway”. What are 505(b)(2) new drug…

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Najib Babul – Opioids for Neuropathic Pain: Worth the Risk?

Published on December 29, 2016 by Dr. Najib Babul Neuropathic pain is pain arising as a direct consequence of a lesion or disease affecting the somatosensory system, or put more simply, pain due to injury to sensory nerves. Neuropathic pain can be broadly divided into peripheral neuropathic pain and central neuropathic pain. Until relatively recently,…

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Can We Make “None Shall be Denied” a Pharma Industry-Wide Vision Statement?

The Indian multinational pharmaceutical company Cipla has a rather “provocative” and “in your face” vision statement which states “None Shall be Denied”. In this general audience post on New Year’s Eve, I ask if we can make “None Shall be Denied” a global pharma New Year’s Eve resolution for 2017 onwards. I also share a few…

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Najib Babul – Discusses How Opiophobia Impacts Pain Relief Efforts in Developing Countries

Physicians attempting to provide palliative care services in developing countries to patients with advanced cancer or HIV/AIDs face substantial hurdles because of opiophobia, an exaggerated fear about the risks of opioid analgesic use. Dr. Najib Babul, an accomplished developer of medicines to treat pain discusses how entrenched opiophobia has adversely impacted the delivery of pain…

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Najib Babul – On the Importance of Recognizing the Unsung Heroes of Pharmaceutical Innovations

Pharmaceutical support services company United BioSource Corporation (UBC) recently launched a marketing campaign celebrating the successes of the pharmaceutical industry, from advancements in HIV, hepatitis C and oncology, to everyday acts of helping patients and answering caregivers’ questions. Amidst a customarily antagonistic media environment “Pharma Heroes” highlights the individual contributions that impact countless patient lives…

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Najib Babul Discusses the Pharmaceutical Industry’s Role in Transforming Global Health

Each year, 1.7 billion citizens of developing countries need treatment for neglected diseases, according to the World Health Organization’s (WHO) 2016 World Health Statistics. In a dynamic global environment, pharmaceutical companies face myriad obstacles in supplying poverty stricken communities with necessary medicines and vaccines. Shareholders often question such pursuits, as the cost-benefit matrix of developing…

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Najib Babul Discusses the Benefits and Limitations of Opioids for Neuropathic Pain

Neuropathic pain is pain arising as a direct consequence of a lesion or disease affecting the somatosensory system, or put more simply, pain due to injury to sensory nerves. Neuropathic pain can be broadly divided into peripheral neuropathic pain and central neuropathic pain. Until relatively recently, a limited number of older tricyclic antidepressants and anti-epileptics…

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