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FDA approves first 3D-printed oral tablet

The antiepileptic drug Spritam (levetiracetam) is the first FDA-approved medication manufactured using three-dimensional printing (3DP). The manufacturer, Aprecia Pharmaceuticals, produces the drug using a unique 3DP method that creates a porous tablet that rapidly disintegrates when it comes into contact with a liquid. Spritam is indicated as adjunctive therapy for treating partial onset seizures in patients with epilepsy age 4 and older weighing more than 20 kg (44 lb), myoclonic seizures in patients age 12 and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in patients age 6 and older with idiopathic generalized epilepsy.


Tablets produced with the new technology are available in 250 mg, 500 mg, 750 mg, and 1,000 mg doses. Each tablet is individually packaged and disintegrates quickly with just a sip of water. The manufacturer expects these patient-friendly features to improve adherence to the medication regimen-especially in children who may resist taking daily medication and in adults who have difficulty swallowing. Missed doses increase the risk of breakthrough seizures.


The new medication is expected to be available in the first quarter of 2016.


Sources: FDA approves the first 3D printed drug product. Aprecia Pharmaceuticals. News release. August 3, 2015. Prescribing information. Spritam (levetiracetam) tablets, for oral use. http://www.spritam.com/pdfs/full-pi.pdf.



Genetic engineering of yeast produces opioid

By genetically altering baker's yeast, scientists have found a way to make these fast-growing cells convert sugar into hydrocodone in just 3 to 5 days. In contrast, the process for creating hydrocodone from opium poppies, the usual source, can take up to a year. As reported in the journal Science, this achievement has important implications for patients in impoverished nations where analgesics are expensive and hard to come by.


At present, the output is small: About 4,400 gallons of bioengineered yeast are needed to produce an opioid dose. But the scientists say the breakthrough is just the beginning. According to senior author Christina Smolke, "The techniques we developed and demonstrated for opioid pain relievers can be adapted to produce many plant-derived compounds to fight cancers, infectious diseases and chronic conditions such as high blood pressure and arthritis."


Sources: Galanie S, Thodey K, Trenchard IJ, Filsinger Interrante M, Smolke CD. Complete biosynthesis of opioids in yeast. Science. 2015;349(6252):1095-1100. Stanford researchers genetically engineer yeast to produce opioids. Stanford University. News release. August 13, 2015.



Second drug approved for aggressive control

The FDA announced approval of evolocumab (Repatha), the second drug in a potent new class of drugs that reduces low-density lipoprotein cholesterol (LDL-C). Administered by subcutaneous injection, evolocumab is indicated as an adjunct to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low LDL-C.


It's also indicated as an adjunct to diet and other LDL-lowering therapies, such as statins, in patients with homozygous familial hypercholesterolemia who require additional lowering of LDL-C.


A proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor antibody, evolocumab increases the number of low-density lipoprotein (LDL) receptors available to clear LDL from the blood, lowering LDL-C levels. The most common adverse reactions are nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.


Allergic reactions, such as rash and urticaria, have also been reported. Teach patients using evolocumab to recognize signs and symptoms of an allergic reaction and seek medical attention immediately if they occur.


Source: FDA approves Repatha to treat certain patients with high cholesterol. FDA. News release. August 27, 2015.



New evidence supports corticosteroid therapy

According to a large retrospective study of hospitalized adults with community-acquired pneumonia (CAP), systemic corticosteroid therapy may reduce mortality by about 3% and the need for mechanical ventilation by about 5%. Researchers analyzed data from 13 clinical trials that involved more than 2,000 patients hospitalized with CAP. The median age of participants was in the 60s, and 60% were male.


Results showed that adjunctive systemic corticosteroid therapy was associated with reductions in all-cause mortality, the need for mechanical ventilation, and acute respiratory distress syndrome. Corticosteroid therapy also decreased the time to clinical stability and reduced the duration of hospitalization by about 1 day. Although the incidence of hyperglycemia requiring treatment increased with adjunctive corticosteroid therapy, the frequency of gastrointestinal hemorrhage didn't increase.


Globally, lower respiratory tract infections are a leading cause of premature death. "Our study should lead to an important change in treatment for pneumonia," said lead author Dr. Reed Siemieniuk. "Corticosteroids are inexpensive and readily available around the world. Millions of patients will benefit from this new evidence."


Sources: Siemieniuk RA, Meade MO, Alonso-Coello P, et al. Corticosteroid therapy for patients hospitalized with community-acquired pneumonia: a systematic review and meta-analysis. Ann Intern Med. [e-pub Aug. 11, 2015] McMaster-led study finds steroid therapy benefits patients with pneumonia. McMaster University. News release. August 10, 2015.



DPP-4 inhibitors linked to joint pain

The FDA has issued a warning that drugs classified as dipeptidyl peptidase-4 (DPP-4) inhibitors-sitagliptin, saxagliptin, linagliptin, and alogliptin-may cause severe and disabling joint pain. The warning will be added to the labels of all DPP-4 inhibitors, which are prescribed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. They can also be included in antidiabetic formulations containing other drugs, such as metformin.


The FDA reports that severe joint pain may develop immediately after starting therapy with a DPP-4 inhibitor or years later. Symptoms generally resolve within a month after the drug is discontinued, but may flare up again if the patient resumes therapy with the same or another DPP-4 inhibitor.


Monitor patients taking DPP-4 inhibitors for joint pain. Tell them to contact their healthcare provider immediately if they experience severe or persistent joint pain, but warn them not to stop treatment without talking with their healthcare provider first. Encourage them to review the Medication Guide issued with their medication.


Source: FDA drug safety communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain. FDA. Safety announcement. August 28, 2015.